BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8096267 · Received November 21, 2018

    Report

    Report Number
    1911916-2018-00684
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    November 6, 2018
    Report Date
    December 21, 2018
    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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: MEDICAL DEVICE EXPIRATION DATE: N/A. MEDICAL DEVICE LOT #: 3060072. DEVICE MANUFACTURE DATE: 201203-01.

    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 3031139 HAD 29 VISUAL INSPECTIONS PERFORMED ON 1,600 PARTS WITH ZERO DEFECTS NOTED. FIVE LEAK TESTS WERE PERFORMED ON 25 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 BD PRECISIONGLIDE NEEDLE IS ¿LEAKING IN PATIENTS MOUTH¿. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRECISIONGLIDE NEEDLE IS ¿LEAKING IN PATIENTS MOUTH¿. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ NEEDLE IS ¿LEAKING IN PATIENTS MOUTH¿. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    935456 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 3060072 30382903051367

    Patients

    Seq Age Sex Outcome Treatment
    1 Other