BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ACCESS KIT (NON-VASCULAR)

    MDR report key: 3123832 · Received May 15, 2013

    Report

    Report Number
    1721504-2013-00111
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DRE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED SUSPECT DEVICE WAS 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 WHILE REMOVING THE WIRE THROUGH THE NEEDLE DURING A NEPHROSTOMY PROCEDURE, THE WIRE UNCOILED. THE WIRE WAS INTRODUCED IN AND OUT OF THE NEEDLE, MULTIPLE TIMES DURING THE PROCEDURE. DURING REMOVAL OF THE WIRE WHEN RESISTANCE WAS MET, THE PHYSICIAN USED A LITTLE MORE FORCE AND THE WIRE CAME OUT WITH THE TIP UNCOILING. THE PHYSICIAN STOPPED AND A SECOND WIRE WAS INSERTED. THE PHYSICIAN THEN REMOVED THE BROKEN WIRE WITHOUT INCIDENT. IT WAS REPORTED THAT DIFFICULT ANATOMY OF THE PATIENT MAY HAVE BEEN A CONTRIBUTING FACTOR. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214889 MINI ACCESS KIT (NON-VASCULAR) DRAINAGE CATHETER AND ACCESSORIES DRE MERIT MEDICAL SYSTEMS, INC. H449216

    Patients

    Seq Age Sex Outcome Treatment
    1 MAK INTRODUCER