BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9156069 · Received October 4, 2019

    Report

    Report Number
    1911916-2019-01045
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 20, 2019
    Report Date
    September 25, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051367
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE (1) PHOTO WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTO SHOWS A NEEDLE NEXT TO A NEEDLE HUB ASSEMBLY WHICH IS ATTACHED TO A SYRINGE. THE NEEDLE APPEARS TO HAVE SEPARATED FROM THE NEEDLE HUB ASSEMBLY. 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. POTENTIAL ROOT CAUSE, A MACHINE MALFUNCTION CAUSED INSUFFICIENT EPOXY TO BE APPLIED TO THE NEEDLE HUB / CANNULA ASSEMBLY WHICH RESULTED IN THE CANNULA NOT BEING SECURED IN THE NEEDLE HUB. BD ACKNOWLEDGES THAT THE RETURNED SAMPLE HAD INSUFFICIENT EPOXY ON THE NEEDLE HUB / CANNULA WHICH RESULTED IN THE NEEDLE PULLING OUT OF THE NEEDLE HUB. THIS IS CONSIDERED A RARE OCCURRENCE AND NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT. 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

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLE CAME OFF THE HUB. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305136. BATCH/LOT: 9030555. IT WAS REPORTED THAT THE NEEDLE CAME OFF THE HUB. CUSTOMER TEXT: DR. WAS GIVING A STEROID INJECTION IN THE SHOULDER FOR THE PATIENT. WHEN SHE WAS INJECTION THE LIDOCAINE FIRST TO HELP NUMB BEFORE GIVING THE STEROID THE NEEDLE CAME OFF THE HUB. THE NEEDLE WAS STUCK IN THE PATIENT SHOULDER. DR. WAS ABLE TO GET THE NEEDLE OUT. SHE DID EXPLAIN TO THE PATIENT WHAT HAD HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953110 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9030555 30382903051367

    Patients

    Seq Age Sex Outcome Treatment
    1 Other