BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS

    MDR report key: 12523268 · Received September 23, 2021

    Report

    Report Number
    1213809-2021-00658
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    April 21, 2021
    Report Date
    September 24, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED THE REPORTED DEFECT COULD NOT BE CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0100479. A REVIEW SHOWED INSUFFICIENT SILICONE ISSUE WAS REPORTED DURING THE PRODUCTION. PRODUCT WAS REQUALIFIED PER APPLICABLE ACCEPTABLE QUALITY LIMIT BEFORE PRODUCTION RESUMED.

    Description of Event or Problem · 0

    IT WAS REPORTED 652 BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS HAD DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER SAID THE PLUNGER IN THE SYRINGE IS NOT WORKING. PRODUCT WAS USED ON PATIENT."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED 652 BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS HAD DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER SAID THE PLUNGER IN THE SYRINGE IS NOT WORKING. PRODUCT WAS USED ON PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417339 BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0100479

    Patients

    Seq Age Sex Outcome Treatment
    1