BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18533331 · Received January 18, 2024

    Report

    Report Number
    2210968-2024-00486
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    December 27, 2023
    Report Date
    January 17, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031022867
    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). 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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL SEPTAL DEFECT (VSD) PROCEDURE ON 27-DEC-2023 AND SUTURE WAS USED. WHEN THE DOCTOR USED A NEEDLE HOLDER TO CLAMP THE NEEDLE FOR EXTRACTION, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. AFTER THE INCIDENT, THE SUTURE WAS REPLACED AND THE VSD REPAIR SURGERY CONTINUED AFTER CONFIRMING THAT EVERYTHING WAS CORRECT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653757 PRLNE HS BLU 24IN 5-0 D/A BV-1 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. TDBEHR 10705031022867

    Patients

    Seq Age Sex Outcome Treatment
    1 Male