BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD UD 18IN 3-0 S/A PS-2 PRM MP

    MDR report key: 20146574 · Received September 5, 2024

    Report

    Report Number
    2210968-2024-09295
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Report Date
    September 5, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031040632
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/5/2024. 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 SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: THE NEW INFORMATION INDICATES THE EVENT HAPPENED ON 4 DIFFERENT OCCASIONS. PLEASE CLARIFY HOW MANY SUTURES PULLED OFF THE NEEDLE DURING EACH PROCEDURE AS 12 PULL OFF SUTURES WERE REPORTED: PROCEDURE 1: 2 SUTURE, PROCEDURE 2: 3 SUTURE, PROCEDURE 3: 4 SUTURE, PROCEDURE 4: 3 SUTURE. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: ¿ WHAT IS THE ACCOUNT NAME? ¿ PLEASE SPECIFY THE TOTAL NUMBER OF NEEDLES THAT POPPED OFF WHILE SUTURING. ¿ PLEASE CLARIFY, WERE THE NEEDLES BREAKING? OR WERE THE NEEDLES DETACHING FROM THE SUTURE THREAD? ¿ DID ALL THE FAULTY SUTURES SHARE THE SAME LOT NUMBER (TCBBDHA0)? ¿ IF NO, PLEASE PROVIDE CORRESPONDING LOT NUMBER FOR EACH DAMAGED SUTURE. ¿ DID THE REPORTED ISSUE OCCUR OVER THE SAME PATIENT PROCEDURE? IF NO, PLEASE CLARIFY THE TOTAL AMOUNT OF PATIENT EVENTS. ¿ ARE THE DAMAGED PRODUCTS AVAILABLE TO BE RETURNED FOR EVALUATION? IF YES, PLEASE CLARIFY HOW MANY WILL BE RETURNED AND TO WHO AND WHERE CAN A RETURN KIT BE SEND FOR RECOLLECTION? ¿ PLEASE CLARIFY HOW MANY PRODUCTS NEED TO BE REPLACED AND PROVIDE REPLACEMENT CONTACT AND FULL ADDRESS. ACCOUNT NAME ¿ (B)(6). AT LEAST 12 NEEDLES POPPED OFF WHILE SEWING NO, NEEDLES DID NOT BREAK. THE SUTURE DETACHED RIGHT AT THE NEEDLE. YES, ALL NEEDLE CAME FROM THE SAME LOT NUMBER. THIS EVENT HAPPENED ON 4 DIFFERENT OCCASIONS. NO, THE SUTURE IS NOT AVAILABLE FOR RETURN. HOW MANY TO BE REPLACED, 12 SUTURE. CONTACT ¿ (B)(6). 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 UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN PROCEDURE, THERE WAS AN ISSUE OF THE NEEDLE COMING OFF THE SUTURE, THERE WERE AT LEAST A DOZEN WHERE THE NEEDLE POPPED OFF WHILE SUTURING. THERE WAS NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287179 VCL CT BRD UD 18IN 3-0 S/A PS-2 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. TCBBDHA0 10705031040632

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown