BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7011974 · Received November 8, 2017

    Report

    Report Number
    1911916-2017-00297
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    October 18, 2017
    Report Date
    October 20, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). INVESTIGATION: QN REVIEW: ONE NOTIFICATION WAS WRITTEN FOR HUB DAMAGE FOR BATCH 5211675. ALL AFFECTED PRODUCT WAS SCRAPPED. DHR REVIEW: ASSEMBLY BATCH 5149541 HAD 60 VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. ASSEMBLY BATCH 5211675 HAD 55 VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH ZERO DEFECTS NOTED. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THE INVESTIGATION CONCLUDED: UNCONFIRMED: 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 ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATTEMPTING TO ADMINISTER MEDICATION, THE MEDICATION LEAKED OUT OF THE WRONG SIDE OF THE 27 G X 1/2 IN. BD PRECISIONGLIDE¿ NEEDLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791597 27 G X 1/2 IN. BD PRECISIONGLIDE¿ NEEDLE NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 5239642 30382903051091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other