BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COTTONY II DACRON, SILKY II POLYDEK

    MDR report key: 13572899 · Received February 21, 2022

    Report

    Report Number
    3004365956-2022-00008
    Event Type
    Malfunction
    Date Received
    February 21, 2022
    Date of Event
    February 3, 2022
    Report Date
    February 7, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A VISUAL, DIMENSIONAL, OR FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER AND PRODUCT CODE WAS NOT PROVIDED. NO CORRECTIVE ACTION CAN BE IMPLEMENTED DUE TO THE LACK OF PRODUCT CODE AND BATCH NUMBER TO PERFORM A PROPER INVESTIGATION TO DETERMINE A ROOT CAUSE. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF PRODUCT SAMPLE AND BATCH NUMBER TO PERFORM A PROPER INVESTIGATION AND TO DETERMINE A ROOT CAUSE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 0

    (B)(4). NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 833-124 / BATCH 74J2000453 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. INCOMING INSPECTION RECORDS OF THE PRODUCT CODE 163624PH INVOLVED IN THE MANUFACTURING OF PRODUCT CODE 833-124 / BATCH 74J2000453 WERE REVIEWED, NO ISSUES OR DISCREPANCIES WERE FOUND. A CORRECTIVE ACTION CANNOT BE IMPLEMENTED AT THE TIME SINCE NO PHOTOS OR SAMPLE INVOLVED IN THE CUSTOMER COMPLAINT WAS NOT SENT FOR ANALYSIS. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED. IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THE COMPLAINT.

    Description of Event or Problem · 0

    BULLET DETACHED FROM SUTURE IN USE. THEY PERFORMED AN XRAY AND THE DETACHED PIECE IS STILL IN THE PATIENT. THEY DID NOT RETRIEVE IT BUT INFORMED THE PATIENT. NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    BULLET DETACHED FROM SUTURE IN USE. THEY PERFORMED AN XRAY AND THE DETACHED PIECE IS STILL IN THE PATIENT. THEY DID NOT RETRIEVE IT BUT INFORMED THE PATIENT. NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2443076 COTTONY II DACRON, SILKY II POLYDEK GAT TELEFLEX MEDICAL 74J2000453

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.