BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BULK, NON-STERILE NEEDLE

    MDR report key: 7475659 · Received May 1, 2018

    Report

    Report Number
    1911916-2018-00178
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    March 25, 2018
    Report Date
    May 10, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWENTY-SIX SAMPLES WERE RETURNED, AND VISUALLY INSPECTED. ALL SAMPLES HAD HOLES IN THE SHIELDS. THE DEFECT OF A BROKEN NEEDLE WAS ALSO ON THE COMPLAINT REPORT. NO BROKEN NEEDLES WERE OBSERVED DURING INSPECTION. BATCH 5302788 HAD 104 VISUAL INSPECTIONS WERE PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. BATCH RECORDS FOR SHIELD BATCH 5327952 SHOW 59 VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS/ISSUES NOTED FOR HOLES IN THE SHIELDS. A SECOND SHIELD BATCH, 6032868, HAD 47 VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS/ISSUES NOTED FOR HOLES IN THE SHIELDS. INVESTIGATION CONCLUSION: THE ROOT CAUSE IS A BENT CORE ON THE SHIELD MOLD.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. (B)(6). 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 A BD¿ BULK, NON-STERILE NEEDLE WAS RECEIVED WITH A BROKEN/DAMAGED NEEDLE PROTECTOR. THE DEVICE WAS NOT USED AND THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318252 BD¿ BULK, NON-STERILE NEEDLE NON-STERILE NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 5302788

    Patients

    Seq Age Sex Outcome Treatment
    1 Other