BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    27 G X 1/2 IN. BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 7002296 · Received November 5, 2017

    Report

    Report Number
    1911916-2017-00295
    Event Type
    Malfunction
    Date Received
    November 5, 2017
    Date of Event
    October 17, 2017
    Report Date
    October 19, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051091
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. INVESTIGATION: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THE INVESTIGATION CONCLUDED BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE 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 INVESTIGATION CONCLUSION: NO SAMPLES OR PHOTOS WERE PROVIDED. AN INVESTIGATION CANNOT BE COMPLETED. NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. DHR REVIEW: ASSEMBLY BATCH 6090856 HAD 50 VISUAL INSPECTIONS PERFORMED ON 2,650 PARTS WITH ZERO DEFECTS NOTED. SIX LEAK TESTS WERE PERFORMED ON 30 PARTS WITH ZERO FAILURES RECORDED. ROOT CAUSE DESCRIPTION: UNABLE TO DETERMINE WITHOUT SAMPLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO 27 G X 1/2 IN. BD PRECISIONGLIDE¿ NEEDLES LEAKED BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781647 27 G X 1/2 IN. BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 6239515 30382903051091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other