BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY)

    MDR report key: 14022190 · Received April 5, 2022

    Report

    Report Number
    MW5108799
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 3, 2022
    Manufacturer
    UNK
    Product Code
    MEG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS WAS NOTED TO BE A PRODUCT ISSUE AND DID NOT REALLY AFFECT PATIENT, WHICH IS WHY A TEST PATIENT WAS SED. NURSE GIVING COVID VACCINE WITH SAFETY SYRINGE "VANISH POINT NEEDLES" SUPPLIED BY PHARMACY DEPARTMENT, NOTICED THAT SAFETY SYRINGES ARE NOT FUNCTIONING CORRECTLY. THE NEEDLE ON THE SYRINGE IS NOT RETRACTING INTO THE SYRINGE FOR SAFETY. NURSING PRACTICE WHEN THIS HAPPENS IS TO PLACE SYRINGE WITH NEEDLE EXPOSED STRAIGHT TO SHARPS CONTAINER, IN FRONT OF VETERAN WITH CAUTION. THIS WAS REPORTED AND RESPECTIVE AFFECTED INDIVIDUALS NOTIFIED, INCLUDING MEDLINE AND PATIENT SAFETY ON 3/9/2022, ALONG WITH ACTION PLANS. PER INFORMATION FROM PHARMACY: THE PHARMACY EMERGENCY PREPAREDNESS MANAGER MET WITH THE PROCUREMENT MANAGER AND VACCINE CLINIC NURSE MANAGER. IT WAS SUSPECTED THAT THE VANISHPOINT SYRINGE LOT NUMBER WHICH HAS BEEN IN USE SINCE (B)(6) (LOT #:0210701) ARE MALFUNCTIONING. ALL OF THESE SYRINGES HAVE BEEN QUARANTINED UNTIL FURTHER NOTICE. A TOTAL OF 1700 NEW VANISHPOINT SYRINGES WITH THREE NEW LOT NUMBERS HAVE BEEN ACQUIRED. MONITORING WILL OCCUR TO ENSURE MALFUNCTIONING IS NOT OCCURRING WITH THESE LOTS. IT IS BELIEVED THAT THE LOT #0210701 HAS CAUSED 15 INCIDENTS SINCE LATE (B)(6) 2022. VANISH POINT SYRINGE/NEEDLE NOT RETRACTING; SUSPECTED LOT# 0210701.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064738 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    1064739 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    1064740 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    1064741 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    940097 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    940098 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    940099 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    940100 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    940101 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    940102 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    940103 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    940104 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    940105 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    940106 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701
    940107 SYRINGE (SYRINGE LMUNDL 27G 0.5IN SAFETY) SYRINGE, ANTISTICK MEG UNK G210701

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male