BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEK BL MF 0 TC-43 2N 48" BSC

    MDR report key: 14686298 · Received June 14, 2022

    Report

    Report Number
    3004365956-2022-00041
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    May 17, 2022
    Report Date
    June 3, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    UDI-DI
    14026704735317
    PMA / PMN Number
    K193530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN#: (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT RETURNED. A FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 833-234 / BATCH 74C2101915 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 IS NOT BEING MANUFACTURED AT THE TIME. IF THE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). DURING THE VISUAL INSPECTION IT WAS DETECTED THAT THE SUTURE IS BROKE IN TWO PARTS, ONE OF THEM HAVE A LENGTH OF 24 INCH AND THE OTHER ONE HAVE A LENGTH OF 24 INCH WITH 1 BULLET ATTACHED AT THE END. THE NEEDLE SHOW SIGNS OF CONTAMINATION AND THE SUTURE HAVE DAMAGE THROUGH THE BODY. DURING THE DIMENSIONAL INSPECTION IT WAS DETECTED THAT THE SUTURE IS BROKE IN TWO PARTS, ONE OF THEM HAVE A LENGTH OF 24 INCH AND THE OTHER ONE HAVE A LENGTH OF 24 INCH. PER OPERATIONAL HAZARDS - INCORRECT OR INAPPROPRIATE OUTPUT OR FUNCTIONALITY - SUTURES ARE INTENDED TO BE USED BY SURGEONS QUALIFIED IN THE APPROPRIATE INDICATION/PROCEDURES / SUTURING DEVICE IFU. THE SUTURE IS NOT DESIGNED FOR USE/COMPATIBILITY WITH OTHER MEDICAL DEVICES. ALL SUTURE MATERIAL IFU'S CONTAIN A CAUTION STATEMENT FOR DEVICE HANDLING. IN SUMMARY, BASED ON THE FINDINGS DURING VISUAL AND DIMENSIONAL INSPECTION, CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE CONDITION OF THE SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE A ROOT CAUSE. NO ISSUES OR DISCREPANCIES WERE FOUND IN THE PRODUCTION DEVICE HISTORY RECORD (DHR) OF THIS PRODUCT. MANUFACTURING PERSONNEL WILL BE NOTIFIED OF THIS EVENT FOR AWARENESS.

    Description of Event or Problem · 0

    TAPERCUT CAME OFF THE SUTURE DURING PLACEMENT IN SACROSPINOUS LIGAMENT. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878695 DEK BL MF 0 TC-43 2N 48" BSC DEKLENE MAXX POLYPROPELENE NON GAW TELEFLEX MEDICAL IPN056766 74C2101915 14026704735317

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown