BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 12841175 · Received November 18, 2021

    Report

    Report Number
    9614033-2021-00138
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Date of Event
    October 20, 2021
    Report Date
    December 17, 2021
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: NINETEEN SEALED 3ML SYRINGES RECEIVED FOR INVESTIGATION FOR LOT NUMBER 1131289. 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. UPON VISUAL INSPECTION OF SAMPLES, ONE SYRINGE WAS FOUND WITH MOLDING DEFECTS. FUNCTIONAL TESTING WAS PERFORMED ON ALL SAMPLES, 16 SYRINGES HAD LEAKAGE DEFECT. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH INSPECTION FAILURE OF THE MOLDING PARTS WHICH INCLUDE MOLDING TEMPERATURE FAILURE, AND INSPECTION PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED 3 BD SYRINGE 3ML LL 200 S/C EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE 3ML SYRINGES, MULTIPLE SYRINGES FAILED, CARE WAS DELAYED, POTENTIAL DOSING CONCERN.

    Description of Event or Problem · 0

    IT WAS REPORTED 3 BD SYRINGE 3ML LL 200 S/C EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE 3ML SYRINGES, MULTIPLE SYRINGES FAILED, CARE WAS DELAYED, POTENTIAL DOSING CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738265 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 309657 1131289 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown