BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEKNATEL MDK VI MFO TC43/HR26

    MDR report key: 3955557 · Received June 13, 2014

    Report

    Report Number
    3004365956-2014-00214
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 26, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GAL
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. NO CORRECTIVE ACTIONS CAN BE IMPLEMENTED DUE TO THE LACK OF PRODUCT SAMPLE AND BATCH NUMBER TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE LACK OF PRODUCT SAMPLE AND BATCH NUMBER TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. HOWEVER, THE MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGED ISSUE: CAPIO DART/BULLET LOST DURING PROCEDURE. X-RAY PERFORMED ON PT. X-RAY DID NOT SHOW BULLET INSIDE PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350693 DEKNATEL MDK VI MFO TC43/HR26 SUTURE/BULLET GAL TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1