BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL VIO 36IN 2-0 S/A FS-1

    MDR report key: 16399865 · Received February 17, 2023

    Report

    Report Number
    2210968-2023-01227
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    January 1, 2023
    Report Date
    March 15, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031218635
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 3/15/2023. 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: COULD YOU PLEASE CLARIFY WHAT WAS DONE WHEN THE NEEDLE POP OFF (REMOVAL FROM PACKAGE /DURING PASSAGE THROUGH TISSUE/ DURING TYING / POST-OP)? PLEASE CLARIFY VETERINARIAN DOING ROUTINE SPAY OF A MEDIUM SIZE DOG. GOING THROUGH SKIN TISSUE AND 1 WHEN LIGATING A MEDIUM SIZED VESSEL. HAPPENED WITH THE SAME DOG WITH 2 PACKAGES OF SUTURE AND HAPPENED WITH THE FOLLOWING DOG SPAY. COULD YOU PLEASE CLARIFY WHAT WAS DONE WHEN THE SUTURE BROKE (REMOVAL FROM PACKAGE /DURING PASSAGE THROUGH TISSUE/ DURING TYING / POST-OP)? PLEASE CLARIFY VETERINARIAN DOING ROUTINE SPAY OF A MEDIUM SIZE DOG. PULLING THROUGH SKIN TISSUE WHEN DOING SQ CLOSURE TYING OFF LIGATURES. HAPPENED WITH THE SAME DOG WITH 2 PACKAGES OF SUTURE AND HAPPENED WITH THE FOLLOWING DOG SPAY. COULD YOU PLEASE CLARIFY IF THE PATIENT SUFFERED FROM ANY SIGNS OR CONSEQUENCES DUE TO THE ISSUE? PLEASE PROVIDE MORE INFORMATION. ADDITIONAL TIME UNDER GENERAL ANESTHESIA DUE TO HAVING TO TAKE TIME TO RETHREAD THE SUTURE ONTO ONE OF OUR DISPOSABLE NEEDLES AND HAVING TO RESTART THE SQ CLOSURE. NO IMMEDIATE CONSEQUENCE TO THE PATIENT BUT MAKING THE VET UNCOMFORTABLE GIVEN THE NEEDLE COULD HAVE FALLEN INTO THE ABDOMEN. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED: WAS THE ADDITIONAL PATIENT PROCEDURE PREVIOUSLY REPORTED TO ETHICON? IF SO, PLEASE PROVIDE THE REFERENCE NUMBER. IF NOT, WHAT IS THE PROCEDURE DATE OF THE ADDITIONAL EVENT? 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. * COULD YOU PLEASE CLARIFY WHAT WAS DONE WHEN THE NEEDLE POP OFF (REMOVAL FROM PACKAGE /DURING PASSAGE THROUGH TISSUE/ DURING TYING / POST-OP)? PLEASE CLARIFY * COULD YOU PLEASE CLARIFY WHAT WAS DONE WHEN THE SUTURE BROKE (REMOVAL FROM PACKAGE /DURING PASSAGE THROUGH TISSUE/ DURING TYING / POST-OP)? PLEASE CLARIFY * COULD YOU PLEASE CLARIFY IF THE PATIENT SUFFERED FROM ANY SIGNS OR CONSEQUENCES DUE TO THE ISSUE? PLEASE PROVIDE MORE INFORMATION. EVENT RELATED TO MW # 2210968-2023-01225, MW # 2210968-2023-01228. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THREE SUTURES HAD THE NEEDLE POP OFF AND THE SUTURE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167130 MCRYL VIO 36IN 2-0 S/A FS-1 SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. Y943G SJMARM 10705031218635

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown