DPS / DUOPROSS MEDITECH (KUNSHAN) CO., LTD. DPS BARE HYPODERMIC SYRINGES; SYRINGE, PISTON
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Lot Number 2010049 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/05/2021 |
Event Type
No Answer Provided
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Event Description
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[dps needles and syringes] treatment under emergency use.Authorization(eua): we would like to report a critical malfunction with the dps bare hypodermic syringes and safety needles supplied in our pfizer covid-19 vaccine ancillary kits.The needle and syringe combination fails to securely attach and results in the needle detaching from the syringe during vaccine administration.Upon withdrawal, the needle remains lodged in the patient's arm.Not only is this a safety issue, we have lost vaccine doses due to leaking from the hub site.
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