BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEK BL MF 0 TC-43/HR 26 2N

    MDR report key: 10504843 · Received September 8, 2020

    Report

    Report Number
    3004365956-2020-00178
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Date of Event
    August 20, 2020
    Report Date
    August 24, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    PMA / PMN Number
    K930738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 833-124 / BATCH 74J1902977 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. A CORRECTIVE ACTION CANNOT BE IMPLEMENTED AT THE TIME SINCE THE 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 THIS COMPLAINT. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY NOR IS BEING MANUFACTURED AT THE TIME. IF THE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS.

    Description of Event or Problem · 0

    ISSUE REPORTED: A SMALL PORTION OF THE SUTURE BROKE OFF AND IS RETAINED IN THE PELVIC BONE OF THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    ISSUE REPORTED: A SMALL PORTION OF THE SUTURE BROKE OFF AND IS RETAINED IN THE PELVIC BONE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970009 DEK BL MF 0 TC-43/HR 26 2N SUTURE, NONABSORBABLE, SYNTHE GAW TELEFLEX MEDICAL 74J1902977

    Patients

    Seq Age Sex Outcome Treatment
    1