BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BLU 24IN 7-0 D/A CC175-8 EP

    MDR report key: 18797284 · Received February 28, 2024

    Report

    Report Number
    2210968-2024-02070
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    February 7, 2024
    Report Date
    February 28, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DATE SENT TO THE FDA: 2/28/2024. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: - WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT - NO - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS (NOT THE PERSON RELAYING/SUBMITTING ANSWERS TO LOC OR CHU) ¿ MR PRATIK GANDHI ¿ OT PHARMACY INCHARGE THE FOLLOWING INFORMATION WAS REPORTED: WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? NO. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. RELATED REPORTS: 2210968-2024-02069.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE ROBOTIC CABG SURGERY, WHILE TYING THE FIRST KNOT THE SUTURE BROKE AWAY AND THIS HAPPENED IN 2 FOILS OF THE SAME BATCH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452406 PROLENE BLU 24IN 7-0 D/A CC175-8 EP SUTURES - NON-ABSORBABLE GAW ETHICON INC. TDBACE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown