BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10541434 · Received September 16, 2020

    Report

    Report Number
    3004365956-2020-00189
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    August 28, 2020
    Report Date
    September 3, 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 · 1

    QN#: (B)(4). NO ISSUES OR DISCREPANCIES WERE FOUND IN THE DEVICE HISTORY RECORD OF PRODUCT CODE 833-124 / BATCH 74C1700088 THAT CAN BE RELATED TO THE FAILURE MODE REPORTED. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: FIRED CAPIO AND UPON PULLING SUTURE OUT OF VAGINA THE SUTURE SNAPPED AND THE CAPIO BULLET WAS FOUND IN THE CAGE OF THE CAPIO HANDLE. THE DOCTOR COMPLETED THE CASE SUCCESSFULLY USING A NEW CAPIO SUTURE. PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005594 DEK BL MF 0 TC-43/HR 26 2N SUTURE, NONABSORBABLE, SYNTHE GAW TELEFLEX MEDICAL 74C1700088

    Patients

    Seq Age Sex Outcome Treatment
    1