BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 21X1 RB

    MDR report key: 8280008 · Received January 25, 2019

    Report

    Report Number
    1911916-2019-00118
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    January 7, 2019
    Report Date
    March 1, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051656
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TEN REPRESENTATIVE SAMPLES WERE RECEIVED FOR EVALUATION. THEY WERE VISUALLY INSPECTED. THE SEALING OF PACKAGING IS GOOD AND ALL THE PLASTIC SHIELD NEEDLES ARE ASSEMBLED. THEY ALL WERE TESTED FOR SHIELD PULL TEST. THE VALUES WERE BETWEEN 2.2LBS TO 2.5LBS; THE SPECIFICATION IS 0.5LBS TO 5.5LBS, THEREFORE FAILURE MODE IS NOT VERIFIED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE 21X1 RB HAD THE NEEDLE CAPS FALL OFF DURING USE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8090568. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2018-03-31. MEDICAL DEVICE LOT #: 8204603. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-07-23. 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 THAT AN UNSPECIFIED NUMBER OF NEEDLE 21X1 RB HAD THE NEEDLE CAPS FALL OFF DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69905 NEEDLE 21X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 00382903051656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other