BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECTON DICKINSON AND COMPANY

    MDR report key: 533496 · Received June 23, 2004

    Report

    Report Number
    MW1032416
    Event Type
    Malfunction
    Date Received
    June 23, 2004
    Date of Event
    June 18, 2004
    Report Date
    June 23, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUB-Q SYRINGE RECEIVED IN PACKAGE WITHOUT SAFETY CAP ON NEEDLE. THIS IS THE THIRD INCIDENT IN 3 MONTHS.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FORM MFR 8/26/04: BD MEDICAL SURGICAL QUALITY ASSURANCE AND REGULATORY AFFAIRS HAS EVALUATED REPORT AND SAMPLE. THE CONDITION REPORTED HAS BEEN CONFIRMED BASED ON THE ACTUAL SAMPLE RETURNED. SYRINGE PACKAGING MACHINES ARE CURRENTLY EQUIPPED WITH MISSING NEEDLE/MISSING SHIELD DETECTORS. SYRINGES WITHOUT NEEDLE SHIELDS ARE NOT LOADED INTO PACKAGES. A VERY SMALL NUMBER OF SYRINGES (LESS THAN 1 IN 100,000) EITHER ESCAPE DETECTION OR LOSE THEIR NEEDLE SHIELDS WHILE BEING LOADED INTO PACKAGES. MANUFACTURING HAS INSTALLED VISION SYSTEMS TO DETECT MISSING NEEDLE SHIELDS FOR SYRINGES THAT HAVE BEEN LOADED INTO PACKAGES. ANY MISSING NEEDLE SHIELD WILL STOP THE MACHINE AND PREVENT ITS RESTART UNTIL THE DEFECTIVE SYRINGE IS REMOVED. A REVIEW OF RECORDS SHOWS THAT THIS LOT WAS MANUFACTURED PRIOR THIS CORRECTIVE ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECTON DICKINSON AND COMPANY 1 ML SUB-Q 26G 5/8 FMF BECTON DICKINSON DG518201 (01)00382903095971

    Patients

    Seq Age Sex Outcome Treatment
    1 NA