BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8103011 · Received November 26, 2018

    Report

    Report Number
    1911916-2018-00680
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 6, 2018
    Report Date
    December 18, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THREE FULL SHELF CARTONS WERE RETURNED IN GOOD CONDITION. TEN RANDOM SAMPLES WERE LEAK TESTED WITH NO ISSUES OR FAILURES NOTED. 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 TESTING PERFORMED ON THE RETURNED SAMPLES WAS 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 6090849 HAD 42 VISUAL INSPECTIONS PERFORMED ON 2,100 PARTS WITH ZERO DEFECTS NOTED. SIX LEAK TESTS WERE PERFORMED ON 30 PARTS WITH ZERO FAILURES RECORDED. ASSEMBLY BATCH 6090850 HAD 11 VISUAL INSPECTIONS PERFORMED ON 700 PARTS WITH ZERO DEFECTS NOTED. ONE LEAK TEST WAS PERFORMED ON FIVE PARTS WITH ZERO FAILURES RECORDED. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. 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 TESTING PERFORMED ON THE RETURNED SAMPLES WAS ACCEPTABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BEFORE TOUCHING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940549 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 6113649 30382903051282

    Patients

    Seq Age Sex Outcome Treatment
    1 Other