BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO-MATIC INSUFFLATION NEEDLE

    MDR report key: 7083362 · Received December 4, 2017

    Report

    Report Number
    MW5073738
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    December 1, 2017
    Report Date
    December 1, 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 NEEDLES, 14 GAUGE, 150 MM, X WOULD NOT PASS LEAK TEST. THE 900-210 FROM LOT # 186236 - EXP DATE: 11/2018. THE 900-200 FROM LOT # 225665 - EXP. DATE 07/11/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860576 PNEUMO-MATIC INSUFFLATION NEEDLE VERRES NEEDLE FHO COOPER SURGICAL 900-100 225665
    860577 PNEUMO-MATIC INSUFFLATION NEEDLE VERRES NEEDLE FHO COOPER SURGICAL 900-210 186236
    860578 PNEUMO-MATIC INSUFFLATION NEEDLE VERRES NEEDLE FHO COOPER SURGICAL 900-210 186236

    Patients

    Seq Age Sex Outcome Treatment
    1