BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 G X 1/2 IN. BD¿ BULK, NON-STERILE NEEDLE

    MDR report key: 6746172 · Received July 27, 2017

    Report

    Report Number
    1911916-2017-00035
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    January 1, 2017
    Report Date
    July 18, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE SEPARATE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 4123882, DEVICE MANUFACTURE DATE: 5/1/2014. MEDICAL DEVICE LOT #: 4179926, DEVICE MANUFACTURE DATE: 6/1/2014. (B)(6). INVESTIGATION SUMMARY: DHR REVIEW: BATCH 4123882 ¿ SIXTY-ONE VISUAL INSPECTIONS WERE PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. BATCH 4179926 ¿ ONE-HUNDRED SEVENTY-TWO VISUAL INSPECTIONS WERE PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. THE RETURNED SAMPLE WAS EXAMINED FOR CUSTOMER¿S REPORTED ISSUE. THE RETURNED SAMPLE REVEALED ADHESIVE SPLATTER ON CANNULA SHAFT. CONCLUSION: BASED ON THE SAMPLE RECEIVED THE INVESTIGATION, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EPOXY WAS FOUND IN THE MIDDLE OF A 30 G X 1/2 IN. BD¿ BULK, NON-STERILE NEEDLE. FOREIGN MATTER WAS FOUND PRIOR TO USE. NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529282 30 G X 1/2 IN. BD¿ BULK, NON-STERILE NEEDLE HYPODERMIC NEEDLES FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other