BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8097445 · Received November 21, 2018

    Report

    Report Number
    1911916-2018-00676
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    November 6, 2018
    Report Date
    December 21, 2018
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMI
    UDI-DI
    30382903051367
    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

    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 2032721 HAD 29 VISUAL INSPECTIONS PERFORMED ON 1,450 PARTS WITH ZERO DEFECTS NOTED. FOUR LEAK TESTS WERE PERFORMED ON 20 PARTS WITH ZERO FAILURES RECORDED. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 2062278. DEVICE MANUFACTURE DATE: 2012-03-02.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PRECISIONGLIDE NEEDLE LEAKED IN THE PATIENTS MOUTH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PRECISIONGLIDE NEEDLE LEAKED IN THE PATIENTS MOUTH.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 A BD PRECISIONGLIDE¿ NEEDLE LEAKED IN THE PATIENTS MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937257 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND COMPANY 2062278 30382903051367

    Patients

    Seq Age Sex Outcome Treatment
    1 Other