BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK BRAND TRANSEPTAL NEEDLE

    MDR report key: 8523190 · Received April 16, 2019

    Report

    Report Number
    MW5085939
    Event Type
    Injury
    Date Received
    April 16, 2019
    Date of Event
    April 2, 2019
    Report Date
    April 12, 2019
    Manufacturer
    COOK, INC.
    Product Code
    FBQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE 2 COOKS TRANS-SEPTAL NEEDLES FROM THIS LOT WOULD NOT PASS THROUGH THE SHEATH (2 DIFFERENT SHEATHS ATTEMPTED). WHEN THEY TRIED A NEW NEEDLE LOT, IT WORKED FINE. THERE WAS NO HARM TO THE PT. THE DEFECTIVE LOT APPEARS TO HAVE A DIFFERENT CURVATURE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310426 COOK BRAND TRANSEPTAL NEEDLE TROCAR FBQ COOK, INC. REF #TSNC-18-71.0/G02364 9227509
    310427 COOK BRAND TRANSEPTAL NEEDLE TROCAR FBQ COOK, INC. REF #TSNC-18-71.0/G02364 9227509

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention