BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEFLEX/ VASCULAR SOLUTIONS

    MDR report key: 7154297 · Received December 28, 2017

    Report

    Report Number
    MW5074268
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    December 16, 2017
    Report Date
    December 27, 2017
    Manufacturer
    TELEFLEX/ VASCULAR SOLUTIONS
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A 5FR DRAINER CENTESIS CATHETER BEING USED FOR PARACENTESIS WHEN THE DRAINER SHEATH DETACHED FROM THE SYRINGE HUB. THE SHEATH BECAME DISLODGED IN THE PATIENT'S ABDOMINAL CAVITY. RETRIEVAL ATTEMPTS WERE UNSUCCESSFUL AND SURGICAL INTERVENTION WAS RECOMMENDED FOR REMOVAL. THE PATIENT DIED BEFORE SURGICAL INTERVENTION DUE TO ADMITTING DIAGNOSIS. DATES OF USE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: PARACENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929770 TELEFLEX/ VASCULAR SOLUTIONS 5 FR DRAINER CENTESIS CATHETER GCB TELEFLEX/ VASCULAR SOLUTIONS 17137342

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR