BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 24IN 6-0 D/A CC-1 MP

    MDR report key: 19938330 · Received August 8, 2024

    Report

    Report Number
    2210968-2024-08202
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    January 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031128262
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO FDA: 8/8/2024 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 PENDING EVALUATION OF RETURNED DEVICE A DEVICE HAS BEEN RECEIVED, HOWEVER IT HAS NOT YET BEEN EVALUATED. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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: - PLEASE CLARIFY HOW MANY PRODUCT WERE USED DURING THIS SINGLE PROCEDURE ¿ 12 - PLEASE CLARIFY HOW MANY DEVICES ARE AVAILABLE FOR RETURN - EVERYTHING WHAT WAS RETURNED FROM THE CUSTOMER HAS BEEN SENT TO CG LABS - PLEASE PROVIDE PRODUCT RETURN STATUS ¿ RETURNED TO CG LABS A DEVICE HAS BEEN RECEIVED, HOWEVER CLARIFICATION IS REQUESTED WHETHER THE PRODUCT BELONGS TO THIS COMPLAINT. THE FOLLOWING INFORMATION WAS REQUESTED: COULD YOU PLEASE CONFIRM THAT 12 SUTURES WERE USED DURING THE SINGLE PROCEDURE, BUT THE ISSUE OF SUTURE BREAKAGE OCCURRED WITH 6 SUTURES. ***IF THIS STATEMENT IS INCORRECT, PLEASE CLARIFY FURTHER REGARDING HOW MANY ACTUAL SUTURES BROKE DURING THE PROCEDURE. RECEIVED PRODUCT CODE W8707 LOT NUMBER THBCBK: 1. COULD YOU PLEASE CLARIFY IF DEVICE LOT NUMBER THBCBK BELONGS TO THIS COMPLAINT? 2. IF NOT, COULD YOU PLEASE CLARIFY IF THE WRONG RECEIVED PRODUCT BELONGS TO A DIFFERENT COMPLAINT? IF SO, CAN YOU PLEASE PROVIDE THE COMPLAINT NUMBER. 3. IF THE DEVICE WAS NOT REPORTED BEFORE, PLEASE PROVIDE MORE DETAILS OF DEVICE MALFUNCTION. 4. IF THE PRODUCT DOESN¿T BELONG TO ANY COMPLAINT, PLEASE LET US KNOW SO WE CAN DISCARD IT OR ADVISE IF THE PRODUCT IS REQUIRED TO BE RETURNED. 5. IF YOU HAVE THE CORRECT COMPLAINT PRODUCT IN YOUR POSSESSION, PLEASE FORWARD THE PRODUCT TO ETHICON AS SOON AS POSSIBLE. IF YOU HAVE ALREADY SENT THE PRODUCT TO ETHICON, PLEASE REPLY TO [email protected] WITH THE UPS, DHL OR FEDEX TRACKER NUMBER.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 8/9/2024. CORRECTED INFORMATION: B1, H1 - UPON REVIEW OF THE PREVIOUS ADDITIONAL INFORMATION REPORTED IN THE INITIAL MEDWATCH, IT WAS DETERMINED THAT THIS EVENT NO LONGER MEETS MALFUNCTION REPORTING CRITERIA. THIS MEDWATCH REPORT IS NO LONGER REPORTABLE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. CARDIAC SURGEON COULD NOT MAKE A KNOT, SUTURE BROKEN ON THE KNOT PLACE. AFTER THEY TOOK ANOTHER SUTURE FROM COMPETITOR AND FINISHED PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2394272 PRLNE BLU 24IN 6-0 D/A CC-1 MP SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. TJBKKC 10705031128262

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown