BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAUT ADAPTOR PORT, 10MM

    MDR report key: 2102964 · Received May 11, 2011

    Report

    Report Number
    3003898360-2011-00234
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 18, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: DEVICE HISTORY RECORD REVIEW, COMPLAINT HISTORY REVIEW. RESULTS: DEVICE HISTORY RECORD REVIEW SHOWED NO SIMILAR ISSUES WERE FOUND DURING THE MFG OR PACKAGE PROCESS OF THIS LOT. COMPLAINT HISTORY REVIEW FROM 04/19/2010 TO 04/19/2011 WAS CONDUCTED. THIS REVIEW SHOWED THREE COMPLAINTS WERE REPORTED. CONCLUSIONS: NO EVAL WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN - THE SAMPLE IS REQUIRED FOR EVAL. IF THE SAMPLE DEVICE BECOMES AVAILABLE, AN EVAL WILL BE PERFORMED AND CORRECTIVE ACTION WILL BE PROVIDED AS REQUIRED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE BALLOON OF THE TROCAR WAS INFLATED AND BURST OUTSIDE OF THE PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAUT ADAPTOR PORT, 10MM ADAPTOR PORT GCJ TELEFLEX MEDICAL NA 01D1000201

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK