BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE¿ PEN NEEDLE

    MDR report key: 7996270 · Received October 23, 2018

    Report

    Report Number
    3006948883-2018-00236
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    September 18, 2018
    Report Date
    October 18, 2018
    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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: THE 2PCS OF RETURNED SAMPLES WERE INVESTIGATED, 1 SAMPLE CANNULA WAS BROKEN, AND FOUND THE ADHESIVE WAS CRACKED; AND ANOTHER ONE MET PRODUCT SPECIFICATION. BASED ON THE INVESTIGATION ABOVE THE COMPLAINT IS NOT A MANUFACTURE ISSUE. THE RETURNED SAMPLE WAS CHECKED WITH OGP, WE FOUND THE CRITICAL DAMAGE MARK ON THE TOP OF THE ADHESIVE BEAD, AND THE DEFORMATION SHOWING ON THE SURFACE OF THE BROKEN NEEDLE POINT THAT WOULD BE CAUSED BY EXCESSIVE FORCE. DHR OF LOT 6155035 WAS REVIEWED AND NO ABNORMALITY FOUND. INVESTIGATION CONCLUSION: THE 2PCS OF RETURN SAMPLES WERE INVESTIGATED, 1 SAMPLE CANNULA WAS BROKEN, AND FOUND THE ADHESIVE WAS CRACKED; AND ANOTHER ONE MET PRODUCT SPECIFICATION. BASED ON THE INVESTIGATION ABOVE THE COMPLAINT IS NOT A MANUFACTURE ISSUE. ROOT CAUSE DESCRIPTION: THE RETURNED SAMPLE WAS CHECKED WITH OGP, WE FOUND THE CRITICAL DAMAGE MARK ON THE TOP OF THE ADHESIVE BEAD, AND THE DEFORMATION SHOWING ON THE SURFACE OF THE BROKEN NEEDLE POINT THAT WOULD BE CAUSED BY EXCESSIVE FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD ULTRA FINE¿ PEN NEEDLE BROKE INSIDE THE PATIENT'S BODY. THE PATIENT HAD BOTH A CT SCAN AND X-RAY AND THE NEEDLE WAS NOT DETECTED. PATIENT WENT IN FOR SURGERY AND NO NEEDLE WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836756 BD ULTRA FINE¿ PEN NEEDLE PEN NEEDLE FMI BD (SUZHOU) 6155035

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention