BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE NS 25GA 3/4IN W/O SILICONE

    MDR report key: 8982450 · Received September 10, 2019

    Report

    Report Number
    1911916-2019-00934
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    July 11, 2019
    Report Date
    August 27, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. INVESTIGATION SUMMARY: TWO (2) SAMPLES AND TWO (2) PHOTOS WERE RETURNED FROM THE CUSTOMER FOR INVESTIGATION. THE RETURNED SAMPLES WERE EXAMINED USING 10X MAGNIFICATION AND IT WAS FOUND THAT BOTH SAMPLES HAVE SMALL HOOKS ON THE END OF THE NEEDLE TIP POINTS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. INVESTIGATION CONCLUSION: BD ACKNOWLEDGES THAT THE RETURNED SAMPLES HAD NEEDLE POINTS WHICH HAD HOOKS ON THE TIP. AS A MEANS OF RAISING AWARENESS TO THE ISSUE OBSERVED BY THE CUSTOMER A QUALITY ALERT WILL BE ISSUED TO THE ASSOCIATES INVOLVED IN THE PRODUCTION OF THIS MATERIAL. THIS ALERT WILL BE SHARED AT SHIFT STARTUP. ROOT CAUSE DESCRIPTION: AFTER THE GRINDING PROCESS THE NEEDLE CAME IN CONTACT WITH A HARD SURFACE CAUSING THE NEEDLE POINT TO BE BENT BACK INTO A HOOK. RATIONALE: ATTENTION. 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.

    Description of Event or Problem · 1

    MATERIAL NO. 301670, BATCH NO. 9023764. IT WAS REPORTED THAT BEFORE USE OF THE NEEDLE NS 25 GA 3/4 IN W/O SILICONE IT WAS FOUND "DURING INCOMING VISUAL INSPECTION, 2 OUT OF 125 PIECES FROM BAG #13 WERE FOUND IDENTIFIED WITH DAMAGED TIPS." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE TO REPORT TWO COMPLAINTS FOR ISSUES REGARDING DAMAGED/BENT TIPS/BENT CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778275 NEEDLE NS 25GA 3/4IN W/O SILICONE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9023764

    Patients

    Seq Age Sex Outcome Treatment
    1 Other