BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE

    MDR report key: 25149534 · Received May 12, 2026

    Report

    Report Number
    2210968-2026-05156
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 29, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031019966
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). DATE SENT TO THE FDA: 5/12/2026. H6: COMPONENT CODE: G07002 - DEVICE NOT RETURNED. H6: COMPONENT CODE: C22 - PHOTO ANALYSIS. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: 1. QUANTITY OF BLOOD LOSS? CONFIRM THE QTY IN CC. ANS: NOT REPORTED, OT MANAGER (B)(6) MENTIONED ONLY OOZING FROM THE SUTURE NEEDLE HOLE. 2. PATIENT WEIGHT? ANS: NOT REPORTED. 3. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-SUTURING; RE-CLOSURE; DRAINAGE)? IF SO, PLEASE SPECIFY. ANS: RE-SUTURE. 4. WHAT IS THE PATIENT¿S CURRENT STATUS? ANS: NOT REPORTED. 5. PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS (E.G. NURSE, SURGEON, ETC). ANS: (B)(6) & PROF DR. (B)(6). 1. WERE ALL REPORTED SUTURES USED IN THE SAME PROCEDURE? ANS: YES, SAME PROCEDURE, CABG. 2. WERE THERE ANY ADVERSE EVENTS (I.E. INFECTION/COMPLICATION ETC) AND/OR PATIENT CONSEQUENCES ASSOCIATED WITH THIS EVENT? ANS: NOT REPORTED AT THIS MOMENT. 3. AS NEEDLE HOLE LEAKAGE WAS MENTIONED IN THE EVENT DESCRIPTION, COULD YOU CLARIFY THE FOLLOWING: I. WHAT TYPE OF BLEEDING OCCURRED AS A RESULT OF THIS ISSUE (E.G. OOZING, ACTIVE BLEEDING)? ANS: OZZING. II. WAS THE BLEEDING SUCCESSFULLY CONTROLLED INTRA-OP? ANS: YES. III. WAS A BLOOD TRANSFUSION REQUIRED? ANS: NO. 4. DID THE ISSUE RESULT IN ADDITIONAL MEDICAL/SURGICAL INTERVENTION (I.E. REVISION SURGERY ETC) FOR THE PATIENT? ANS: NOT REPORTED AT THIS MOMENT. 5. WHAT IS THE PATIENT¿S CURRENT STATUS? ANS: NO REPORTED AT THIS MOMENT. 6. ARE THE DEVICES AVAILABLE FOR RETURN? IF NO, COULD YOU PROVIDE THE STATUS OF THE DEVICES (E.G. DISCARDED ETC). ANS: NO, DISCARDED DUE TO BIO-HAZARD. 1. MAY I CONFIRM IF THE SUTURES ARE ALL USED IN THE SAME PROCEDURE? ANS: YES, SAME PROCEDURE BY SAME SURGEON. NO SUTURE TO BE RETURN. OT SISTER SAID ITS BIOHAZARD. 2. THE NEEDLE HOLE LEAKAGE INDICATED THERE IS BLEEDING DURING SURGERY, RIGHT? MANAGED TO STOP THE BLEEDING DURING PROCEDURE? WAS BLOOD TRANSFUSION REQUIRED? ANS: NO. OZZING KIND OF BLEEDING COZ NEEDLE PUNCH HOLE AT SAME AREA. THE 7TH SUTURE ONLY ABLE TO USE. ALL EITHER HALFWAY SNAPPED OR WHEN DONE SUTURING SNAPPED DURING TYING KNOTS." H3: PHOTO ANALYSIS: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS THREE SINGLE BARRIER FOLDERS LABELED 8735 PRODUCT CODE USED WITH THE DISPENSED SUTURE. THE SUTURE APPEARS DAMAGED, CUT INTO SEVERAL SECTIONS. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE PHOTO REVIEW, THE EVENT REPORTED IS CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE DEVICE WAS NOT RETURNED OUR EVALUATION IS LIMITED. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. WE VALUE YOUR ASSISTANCE IN PROVIDING US AN OPPORTUNITY TO EVALUATE THE REPORTED EVENT AS ALL INFORMATION REPORTED TO OUR COMPANY IS CRITICAL TO OUR CONTINUOUS IMPROVEMENT EFFORTS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. 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 A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SUTURES SNAPPED DURING CABG ON DISTAL ANASTOMOSIS OF LIMA. SOME OF IT HAPPENED DURING THE SUTURING AND EVEN HAPPENED WHEN TYING KNOT AFTER ANASTOMOSIS. PROBLEM RESOLVE WHEN OPENED THE 7TH SUTURE FROM A DIFFERENT BATCH NUMBER. DISCOVERED NEEDLE HOLE LEAKAGE DUE TO SUTURING A FEW TIMES ON THE DISTAL ANASTOMOSIS OF LIMA, APPLIED HEMOSTATS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280759 PROLENE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. TDBDUK 10705031019966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown