BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMA KIT: 8.5 FR

    MDR report key: 3130234 · Received May 22, 2013

    Report

    Report Number
    3006425876-2013-00091
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K840455
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN THAT THERE HAVE BEEN A COUPLE OF MISHAPS USING THE TRAUMA KIT. HE THINKS IT IS PARTLY HUMAN ERROR AND THE LINE IS TOO SHORT. THE LINE HAD NOT BEEN SUTURED AND SO IT MIGRATED OUT DURING THE RESUSCITATION PROCEDURE. HE STATES THAT THE PT SURVIVED AND IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227161 TRAUMA KIT: 8.5 FR THORACIC CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK