BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECKVISTA ACCESS BALLOON PORT 10MMX70MM

    MDR report key: 3960178 · Received June 24, 2014

    Report

    Report Number
    3003898360-2014-00395
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. HOWEVER, MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SCRUB NURSE THAT DURING USE ON A PATIENT, THE BALLOON BURST DURING A LAP NEPHRECTOMY. NO PIECES REMAINED INSIDE THE PATIENT. THE VOLUME WAS 10ML TO EACH PORT OF SALINE. THE ONLY CONSEQUENCE TO THE PATIENT WAS THAT THE PROCEDURE TOOK SLIGHTLY LONGER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367191 WECKVISTA ACCESS BALLOON PORT 10MMX70MM OPTICAL PORT GCJ TELEFLEX MEDICAL 01H1300362

    Patients

    Seq Age Sex Outcome Treatment
    1