BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 30IN 6-0 D/A C-1

    MDR report key: 20289938 · Received September 24, 2024

    Report

    Report Number
    2210968-2024-10191
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    September 4, 2024
    Report Date
    September 24, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031019430
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 10/16/2024 CORRECTED INFORMATION: B1, H1 - ADDITIONAL INFORMATION WAS RECEIVED THAT THIS EVENT NO LONGER MEETS MALFUNCTION REPORTING CRITERIA. THIS MEDWATCH REPORT IS BEING VOIDED. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: 1. PLEASE PROVIDE LOT NUMBER. ANS: TMBHES 2. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? ANS: NO PATIENT IMPACT. 3. PLEASE CONFIRM THE QUANTITY OF DEVICES INVOLVED IN THE REPORTED EVENT. ANS: 1 UNIT 4. PLEASE CONFIRM THE QUANTITY OF DEVICES AVAILABLE FOR PRODUCT RETURN. ANS: 1 UNIT 5. PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ). ANS: ANSWERED BASED ON COMPLAINT EVENT DESCRIPTION AND RETURNED COMPLAINT DEVICE. 6. PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. ANS: DEVICE SHIPPED TO (B)(6) ON 27 SEP 2024 VIA FEDEX ¿ (B)(4). 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). 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 DEVICE NOT RETURNED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. PHOTOS UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PHOTO EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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. PLEASE PROVIDE LOT NUMBER. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? PLEASE CONFIRM THE QUANTITY OF DEVICES INVOLVED IN THE REPORTED EVENT . PLEASE CONFIRM THE QUANTITY OF DEVICES AVAILABLE FOR PRODUCT RETURN. PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ). PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE CV SURGEON WAS PERFORMING PROXIMAL ANASTOMOSIS, THE SUTURE DID NOT DETACH FROM THE SWAGE, BUT IT SNAPPED IN THE MIDDLE. THE ANASTOMOSIS WAS RE-DONE. THE PROCEDURE WAS DELAYED BY 30-60 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016878 PRLNE BLU 30IN 6-0 D/A C-1 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. TMBHES 10705031019430

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown