BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8605569 · Received May 13, 2019

    Report

    Report Number
    3004365956-2019-00128
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    April 9, 2019
    Report Date
    May 6, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GAW
    PMA / PMN Number
    K930738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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 74C1700091 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 SINCE THE PRODUCT SAMPLE INVOLVED IN THE COMPLAINT NOTIFICATION WAS NOT PROVIDED TO PERFORM A PROPER INVESTIGATION.

    Description of Event or Problem · 0

    MEDWATCH 5085899. IT WAS REPORTED THAT THE TINY BULLET TYPE NEEDLE DETACHED FROM THE SUTURE MATERIAL DURING A VAGINAL HYSTERECTOMY. THE PHYSICIAN WAS UNABLE TO RETRIEVE; NEEDLE INTENTIONALLY LEFT IN PATIENT TO AVOID ANY TRAUMA TO THE PATIENT. THIS WAS DISCLOSED TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    MEDWATCH 5085899. IT WAS REPORTED THAT THE TINY BULLET TYPE NEEDLE DETACHED FROM THE SUTURE MATERIAL DURING A VAGINAL HYSTERECTOMY. THE PHYSICIAN WAS UNABLE TO RETRIEVE; NEEDLE INTENTIONALLY LEFT IN PATIENT TO AVOID ANY TRAUMA TO THE PATIENT. THIS WAS DISCLOSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397752 DEK BL MF 0 TC-43/HR 26 2N SUTURE, NONABSORBABLE, SYNTHE GAW TELEFLEX MEDICAL 74C1700091

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.