BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 12421459 · Received September 3, 2021

    Report

    Report Number
    1911916-2021-00922
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 6, 2021
    Report Date
    August 9, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED BY HEALTH PROFESSIONAL THAT THERE IS A STRINGY LIQUID SUBSTANCE FOUND IN THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WITH A NEEDLE ASSEMBLY CONNECTED TO IT WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. AT THE BOTTOM OF THE SYRINGE BARREL IT IS POSSIBLE TO OBSERVE THE SILICONE THAT IS APPLIED TO THE RUBBER STOPPER. THE SILICONE IS MEDICAL GRADE AND IS APPLIED TO HELP THE PLUNGER ROD-RUBBER STOPPER MOVE SMOOTHLY INSIDE THE BARREL. THE AMOUNT OF SILICONE SEEN IS CONSIDERED ACCEPTABLE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302830, LOT NUMBER 1113475. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE SYRINGE 20ML LL S/C 48. IT WAS REPORTED BY THE HEALTH PROFESSIONAL THERE IS A STRINGY LIQUID SUBSTANCE FOUND IN THE SYRINGE. STATES THERE WAS AN ABNORMALLY LARGE AMOUNT OF LIQUID IN THE SYRINGE AND IT WAS "STRINGY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321975 SYRINGE 20ML LL S/C 48 PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302830 1113475 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1