BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO-MATIC INSUFFLATION NEEDLE

    MDR report key: 7058947 · Received November 27, 2017

    Report

    Report Number
    MW5073559
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    November 21, 2017
    Report Date
    November 22, 2017
    Manufacturer
    COOPER SURGICAL
    Product Code
    FHO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COOPER SURGICAL, PNEUMO-MATIC INSUFFLATION NEEDLE (14 GAUGE), DID NOT PASS OCCLUSION TEST PRIOR TO USE. THE DEFECTIVE NEEDLE WAS REMOVED FROM THE FIELD AND EXCHANGED FOR ANOTHER "LIKE" PRODUCT THAT WORKED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841357 PNEUMO-MATIC INSUFFLATION NEEDLE VARESS NEEDLE FHO COOPER SURGICAL 900-200 225665

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR