BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PEN NEEDLE¿ 31GX5MM 7 PACK

    MDR report key: 8471108 · Received April 1, 2019

    Report

    Report Number
    3006948883-2019-00232
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    March 11, 2019
    Report Date
    March 15, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. INVESTIGATION SUMMARY: DHR OF LOT 8123354 WAS REVIEWED AND NO QN FOUND. INCOMING INSPECTION REPORT OF THE CANNULA WHICH USED FOR THIS LOT, AND ALL TEST RESULTS(STIFFNESS/ RESISTANCE TO BREAKAGE) MEET THE SPECIFICATION. INSPECTED 7PCS RETENTION PARTS ANGLE AND APPEARANCE, ALL RESULTS PASSED. BASED ON THE RESULTS OF RETURNED SAMPLES REVIEWED, WE FOUND THE CRITICAL DAMAGE MARK ON THE TOP OF ADHESIVE BEAD, IT WOULD BE CAUSED BY EXTERNAL EXCESSIVELY FORCE. BASE ON INVESTIGATION ABOVE, THE COMPLAINT IS NOT MANUFACTURE ISSUE. ROOT CAUSE DESCRIPTION: THE RETURNED SAMPLES WERE CHECK AND FOUND THE CRITICAL DAMAGE MARK ON THE TOP OF ADHESIVE BEAD, IT WOULD BE CAUSED BY EXTERNAL EXCESSIVE FORCE. RATIONALE: BASED ON THE CURRENT INVESTIGATION, THE COMPLAINT IS NOT MANUFACTURE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE BROKE OFF BD PEN NEEDLE¿ 31GX5MM 7 PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED TO HAVE REQUIRED 2 SURGERIES TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261409 BD PEN NEEDLE¿ 31GX5MM 7 PACK PEN NEEDLES FMI BD (SUZHOU) 8123354

    Patients

    Seq Age Sex Outcome Treatment
    1 Other