BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL W/O DN

    MDR report key: 10429364 · Received August 20, 2020

    Report

    Report Number
    1213809-2020-00555
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    July 29, 2020
    Report Date
    September 15, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES. D.10 RETURNED TO MANUFACTURER ON: 2020-08-26. H.6. INVESTIGATION SUMMARY: SIX 1ML SYRINGES IN BLISTER PACKS FROM BATCH: 8001745 (P/N: 309628) WERE RECEIVED AND EVALUATED. FIVE PACKAGES WERE FULLY SEALED, AND ONE WAS OPENED. ALL THE SYRINGES APPEARED TO BE PROPERLY ASSEMBLED WITH ALL COMPONENTS PRESENT. NO DEFECT WAS OBSERVED. FURTHERMORE, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1ML LL W/O DN HAD A MOLDING DEFECT, SHORT SHOTS ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECENTLY WE HAVE NOTICED THAT THE "STAMP STOP" (RESISTANCE THAT PREVENTS THE SYRINGE STAMP FROM BEING PULLED OUT) IS MISSING."

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1ML LL W/O DN HAD A MOLDING DEFECT, SHORT SHOTS ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RECENTLY WE HAVE NOTICED THAT THE "STAMP STOP" (= RESISTANCE THAT PREVENTS THE SYRINGE STAMP FROM BEING PULLED OUT) IS MISSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899451 SYRINGE 1ML LL W/O DN PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9260035 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other