BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLVE LOCKING DRAINAGE CATHETER

    MDR report key: 3779405 · Received April 17, 2014

    Report

    Report Number
    1721504-2014-00081
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE RETURNED FOR EVALUATION. THE EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING A CHEST TUBE DRAINAGE CATHETER EXCHANGE, THE LOCKING STRING OF THE DRAINAGE CATHETER WRAPPED AROUND THE WIRE ON THE END OF THE CATHETER. BOTH THE CATHETER AND WIRE HAD TO BE REMOVED. THE PHYSICIAN WAS UNABLE TO REGAIN ACCESS AT THE SAME SITE AND THE PT HAD TO COME BACK THE NEXT DAY TO HAVE A NEW CATHETER PLACED. NO PT HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236442 RESOLVE LOCKING DRAINAGE CATHETER CATHETER, IRRIGATION GBX MERIT MEDICAL SYSTEMS, INC. H573185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention