BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BLU 75CM M0.5

    MDR report key: 13588551 · Received February 23, 2022

    Report

    Report Number
    2210968-2022-01254
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    January 1, 2021
    Report Date
    February 23, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT NUMBER: (B)(4). DATE SENT TO THE FDA: 2/23/2022 (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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT TISSUE WAS BEING APPROXIMATED OR SUTURED WHEN IT BROKE? THE ARTERIAL WALLS OR ARTERY/VEIN ANASTOMOSIS WHAT WAS USED TO COMPLETE THE PROCEDURE? SUTURE REINFORCEMENT WITH 6/0 WAS THE NEEDLE PIECE REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE? NO PLEASE CLARIFY, HOW MANY SUTURE/NEEDLE PULL OFFS OCCURRED DURING SUTURING ? SEVERAL, A DOZEN? BUT THE CHANGE OF THREAD BOXES AND BATCHES DID NOT CHANGE ANYTHING. I HAVE TO DO THE SUTURE WITH 6/0. PLEASE CLARIFY, HOW MANY SUTURE BREAKAGE OCCURRED DURING SUTURING ON THIS ONE PATIENT DURING THIS SINGLE SURGICAL PROCEDURE? ONLY ONE: THE ANASTOMOTIC OVERJET IS ALWAYS CONTINUOUS... WHAT TISSUE/LOCATION WAS SUTURING WHEN PULL OFF OCCURRED? / WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THIS SUTURE NEEDLE PULL OFF EVENT? NO CONSEQUENCE FOR THIS TIME. PROCEDURE NAME AND DATE? / 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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANASTAMOSIS PROCEDURE IN (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD BREAKS, IT IS TOO FRAGILE AND THE NEEDLE PULLED OFF FROM THE THREAD WHEN OVERLOCKING BLOOD VESSELS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080298 PROLENE BLU 75CM M0.5 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. QMBBQT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown