BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL+ VIO 36IN 2-0 S/A CT-1

    MDR report key: 24604152 · Received March 16, 2026

    Report

    Report Number
    2210968-2026-02602
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 9, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031046429
    PMA / PMN Number
    K050845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) DATE SENT TO THE FDA: 3/16/2026. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. 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: DID THIS EVENT CONTRIBUTE TO ANY PATIENT ADVERSE EVENT? IF YES, PLEASE EXPLAIN. ANY PHOTOS AVAILABLE FOR VISUAL ANALYSIS? PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP). 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. THE FOLLOWING INFORMATION WAS RECEIVED: ETHICON SUT MONO PLUS 2-0 SA CT-1 36" 36CT (MCP345H) SUTURE IS NOT 19MM THAT WAS WITHIN THE PACKAGING. POSSIBLE MANUFACTURER ISSUE WHERE THE OUTSIDE PACKAGING SAYS ONE (MM) SIZE WHILE INSIDE THE PRODUCT IS DIFFERENT(MM). IN ADDITION, BREAKING IS COMMON AND THE SUTURE IS NOT STAYING WITHIN. ETHICON SUT MONOCRYL 2-0 SA CP-1 27" 36CT (Y266H) SUTURE IS NOT 19MM THAT WAS WITHIN THE PACKAGING. POSSIBLE MANUFACTURER ISSUE WHERE THE OUTSIDE PACKAGING SAYS ONE (MM) SIZE WHILE INSIDE THE PRODUCT IS DIFFERENT(MM). IN ADDITION, BREAKING IS COMMON AND THE SUTURE IS NOT STAYING WITHIN.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: H 6. MEDICAL DEVICE PROBLEM CODE. ADDITIONAL INFORMATION: H6 6. TYPE OF INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT IS THE SIZE OF THE SUTURES RECEIVED? 36MM. WERE ALL SUTURES THIS SIZE OR ONLY SOME? ALL THIS SIZE. IF POSSIBLE, PLEASE CONFIRM THE QUANTITY: 36. WAS THERE ANY EVIDENCE THAT THE SUTURES WERE DEFECTIVE UPON OPENING THE INDIVIDUAL PACKAGING (E.G., BREAKAGE OR FRAYING)? YES EACH TIME WE USED THEM THEY WOULD BREAK OFF NEEDLE WHEN PULLED AWAY FROM TISSUE. SUTURE BREAKING WAS ALSO MENTIONED. WHEN DID THE ALLEGED DEFICIENCY OCCUR ¿ REMOVAL FROM PACKAGE, HANDLING PRIOR TO THEIENT USE, PASSAGE THROUGH TISSUE, DURING TYING, OR --POST-OP? IF DIFFERENT, PLEASE EXPLAIN. YES WHEN PULLING FROM TISSUE. IF POSSIBLE, PLEASE CONFIRM HOW MANY SUTURES BROKE FROM LOT 10ASZL AND HOW MANY FROM LOT 107S5M. 3 AND 2. "THE SUTURE IS NOT STAYING WITHIN" WAS ALSO REPORTED. COULD YOU PLEASE PROVIDE ADDITIONAL DETAILS ABOUT THIS ISSUE? THE SUTURE BREAKS OFF THE NEEDLE SLIDES OUT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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 A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE IS NOT 19MM THAT WAS WITHIN THE PACKAGING. POSSIBLE MANUFACTURER ISSUE WHERE THE OUTSIDE PACKAGING SAYS ONE (MM) SIZE WHILE INSIDE THE PRODUCT IS DIFFERENT (MM). IN ADDITION, BREAKING IS COMMON AND THE SUTURE IS NOT STAYING WITHIN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664999 MCRYL+ VIO 36IN 2-0 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. 107S5M 10705031046429

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown