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510(k) Data Aggregation
K Number
K032517Device Name
MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE
Manufacturer
Date Cleared
2004-05-18
(278 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
MEDSAFE TECHNOLOGIES LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MedSafe ClickSafe™ syringe is a 3cc sterile, non-toxic, non-pyrogenic, disposable, manually activated, plunger type, anti-stick syringe with integral hypodermic needle. Its primary intended use and indication for use is to provide safe, accurate and reliable method of injecting medication into a patient, subcutaneous as well as intramuscular. Needle retraction is activated by the syringe user after removing the needle from the patient first. Its secondary intended use and indication for use is to retract and contain the contaminated needle after injection and render the syringe inoperable for further injections while not introducing any additional steps to the one-handed operation method, for the purpose of aiding in the prevention of accidental needle stick injuries that would be occurring between removing the needle from the patient and disposing it into the Sharps container.
Device Description
The MedSafe ClickSafe™ Syringe is a 3cc, sterile, non-toxic, non-pyrogenic, disposable, manually activated, plunger type, Anti-Stick syringe with integral hypodermic needle, as detailed within this submission and in relevant patents. The primary intended use of the device is to give safe and accurate subcutaneous and intramuscular injections. Its secondary intended use is to retract and contain the contaminated needle after injection and render the syringe inoperable for further injections while not introducing any additional steps to the one-handed operating method, for the purpose of aiding in the prevention of accidental needle stick injuries. The MedSafe Safety Syringe operates in the same manner as standard hypodermic syringes, prior to the actuation of the safety mechanism. The plunger is retracted as the medication is drawn up to the desired amount. Next, the medication is administered to the patient in the usual way, by inserting the needle into the patient's tissue and depressing the plunger. Figure 1 shows the syringe in its configuration after the medication has been expelled and before the actuation of the safety mechanism. The various parts are identified therein, including the plunger, the boot, the body (barrel) and the needle, all of which are common to standard syringes. The difference is that the boot in the MedSafe syringe is rupturable and the plunger is hollow. The needle is held by the needle hub, which is in turn held in place by the base, which also serves to seal the medication in the syringe. The base is held in place at its plunger-end by an interior shelf in the body. There is a spring around the needle which is held in place by the nose and bears against the needle hub. Once the medication is expelled, the continued depression of the plunger causes the base (which contains the entire needle assembly) to slide, thereby compressing the spring. Continued depression of the plunger drives the needle hub against the nose and pushes the base over the needle hub. As the needle hub exits the base, it stretches the boot which subsequently ruptures. At this time, the compressed spring propels the needle and hub into the hollow plunger, where it is caught and secured by the needle catch (integral to the plunger). Thus, the "dirty" needle is securely held out of harm's way inside the plunger, as depicted in Figure 2. After use, the healthcare worker disposes of the syringe in a sharps container in accordance with OSHA regulations.
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