BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8102820 · Received November 26, 2018

    Report

    Report Number
    1911916-2018-00712
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 6, 2018
    Report Date
    December 21, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051282
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE FULL SHELF CARTON WAS RETURNED IN GOOD SHAPE. FIVE RANDOM SAMPLES WERE PULLED FROM THE SHELF CARTON AND LEAK TESTED. NO FAILURES OR ISSUES WERE OBSERVED. WE ARE UNABLE TO DETERMINE A ROOT CAUSE BASED ON THE COMPLAINT, THE FACT THAT THERE WERE NO ISSUES DURING ASSEMBLY, AND THE RESULTS OF THE TESTING PERFORMED ON THE RETURNED SAMPLES WERE ACCEPTABLE. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED. ASSEMBLY BATCH 8079763 HAD 23 VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS OR ISSUES NOTED. FOUR LEAK TESTS WERE PERFORMED ON 20 PARTS WITH ZERO FAILURES RECORDED. ASSEMBLY BATCH 8093761 HAD 90 VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS OR ISSUES NOTED. FIFTEEN LEAK TESTS WERE PERFORMED ON 75 PARTS WITH ZERO FAILURES RECORDED NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE NEEDLE LEAKED IN THE PATIENT'S MOUTH.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (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 THE BD PRECISIONGLIDE¿ NEEDLE LEAKED IN THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944251 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8093756 30382903051282

    Patients

    Seq Age Sex Outcome Treatment
    1 Other