BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL

    MDR report key: 12579220 · Received October 5, 2021

    Report

    Report Number
    1213809-2021-00691
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 7, 2021
    Report Date
    October 22, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1ML LL PLUNGER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE PLUNGERS CONTINUE TO GET STUCK, THE CUSTOMER HAS TO PUSH REALLY HARD TO GET INJECTION. VERBATIM: CONSUMER REPORTED ABLE TO DRAW UP HIS TESTOSTERONE MEDICATION WITH THE DRAWING UP NEEDLE WITH EASE. WHEN PLACES THE INJECTING NEEDLE ON THE SYRINGE THE PLUNGER WILL NOT BUDGE. ALWAYS FILLS THEN INJECTS RIGHT AWAY. PLACES AIR INTO VIAL. USER FOR SEVERAL YEARS. FINDING ISSUES WITH NOT JUST THIS BOX/LOT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1082583. MEDICAL DEVICE EXPIRATION DATE: 2026-03-31. DEVICE MANUFACTURE DATE: 2021-05-26. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1ML LL PLUNGER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE PLUNGERS CONTINUE TO GET STUCK, THE CUSTOMER HAS TO PUSH REALLY HARD TO GET INJECTION. VERBATIM: CONSUMER REPORTED ABLE TO DRAW UP HIS TESTOSTERONE MEDICATION WITH THE DRAWING UP NEEDLE WITH EASE. WHEN PLACES THE INJECTING NEEDLE ON THE SYRINGE THE PLUNGER WILL NOT BUDGE. ALWAYS FILLS THEN INJECTS RIGHT AWAY. PLACES AIR INTO VIAL. USER FOR SEVERAL YEARS. FINDING ISSUES WITH NOT JUST THIS BOX/LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474522 SYRINGE 1ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown