BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 5IN 10-0 S/A BV75-3

    MDR report key: 18425138 · Received January 2, 2024

    Report

    Report Number
    2210968-2024-00007
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    October 16, 2023
    Report Date
    January 2, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    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). DATE SENT TO THE FDA: 1/2/2024. 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: IT WAS MENTIONED THAT "ENCLOSED PLEASE FIND DEFECT PHOTO" HOWEVER NO PHOTO WAS AVAILABLE ON THE FILE. COULD YOU PLEASE UPLOAD THE PHOTO FOR VISUAL ANALYSIS? PLEASE SEE ATTACHED PHOTO. PLEASE PROVIDE THE LOT NUMBER. * WHAT IS THE PROCEDURE NAME CONTACTED WITH THE SALES REP TODAY VIA PHONE, PLEASE REFER TO THE EVENT DESCRIPTION AND OTHER INFORMATION REQUESTED IS UNKNOWN. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. THE RETURNED PRODUCT DETERMINED THAT IT WAS RECEIVED, ONE UNOPENED SAMPLES THAT PERTAINS TO PRODUCT CODE W2790. DURING THE VISUAL INSPECTION OF THE OVERWRAP PACKET, A SUTURE PIECE MATERIAL IN THE SEAL AREA WAS FOUND, COMPROMISING THE STERILE BARRIER. BASED ON THE INFORMATION CURRENTLY AVAILABLE, SUTURE IN THE SEAL WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE ETHICON QUALITY SYSTEM. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS REPORTED THAT WHEN PREPARING FOR USE BEFORE SURGERY, IT WAS FOUND THAT THE SUTURE IS PRESSED ONTO THE PACKAGING EDGE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418996 PRLNE BLU 5IN 10-0 S/A BV75-3 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. SEBAPZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown