BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE HS BLU 24IN 5-0 D/A BV-1 EP

    MDR report key: 22019616 · Received May 14, 2025

    Report

    Report Number
    2210968-2025-05351
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 4, 2025
    Report Date
    May 14, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031233478
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: - WERE THERE PATIENT CONSEQUENCES? IF YES, PLEASE EXPLAIN. --RECEIVED INFORMATION AS FOLLOWING FROM SALES REP VIA PHONE TODAY. PLEASE REFER TO THE EVENT DESCRIPTION, OTHER INFORMATION REQUESTED IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL REPAIR OF VENTRICULAR SEPTAL DEFECT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, MEDICAL STAFF USED SUTURE IN ACCORDANCE WITH THE OPERATING PROCEDURES DURING THE SURGERY. DURING THE SUTURING PROCESS, THE PROBLEM OF PULLING OFF SUTURE NEEDLE SUDDENLY HAPPENED AND THE SUTURING OPERATION COULD NOT BE COMPLETED. STOPPED USING THE SUTURE IMMEDIATELY TO AVOID FURTHER AFFECTING THE SURGERY. CHANGED ANOTHER ONE AND THE SUTURING OPERATION WAS PERFORMED AGAIN. THE PATIENT WAS CLOSELY OBSERVED TO ENSURE SAFETY DURING THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968093 PRLNE HS BLU 24IN 5-0 D/A BV-1 EP SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. TMBCBT 10705031233478

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown