BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORBABLE SUTURES

    MDR report key: 23426638 · Received October 30, 2025

    Report

    Report Number
    3004365956-2025-00062
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 7, 2025
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    NON
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ONE EMPTY CARRIER OF CODE 833-234 (DEK BL MF 0 TC-43 2N 48" BSC) AND A SECTION OF BLUE SUTURE THREAD WAS RECEIVED FOR EVALUATION INSIDE A ZIPLOC BAG, WITH A DISINFECTION TAG. DURING VISUAL INSPECTION, IT WAS FOUND THAT A EMPTY CARRIER WITH SIGHTS OF CONTAMINATION. IN ADDITION, A SECTION OF SUTURE THREAD WAS FOUND INSIDE THE ZIPLOC BAG WITHOUT ITS ORIGINAL PACKAGING AND WITHOUT ANY BULLETS ATTACHED TO IT. THE SAMPLE WAS NOT RECEIVED IN ITS ORIGINAL PACKAGING. IT WAS VISUALLY INSPECTED AND IT WAS OBSERVED THAT THE SUTURE SHOWED SIGNS OF MANIPULATION, MARKS AND DAMAGE. THE CUSTOMER'S COMPLAINT CANNOT BE CONFIRMED AS A MANUFACTURING DEFECT, AS THE SAMPLE IS NOT IN ITS ORIGINAL PACKAGING, THE SAMPLE DOES SHOW SIGNS OF MANIPULATION, MARKS AND DAMAGE POSSIBLY CAUSED DURING INTERACTION WITH A DEVICE, NO BULLET OR NEEDLE WAS PROVIDED IN SAMPLE. THERE IS NOT ENOUGH EVIDENCE THAT SHOWS THAT THE DAMAGE WAS CAUSED DURING THE MANUFACTURING PROCESS, ADDITIONALLY IT IS UNKNOWN IF A FORCE BEYOND THE ALLOWED WAS APPLIED AT THE BULLET/SUTURE UNION DURING USE. A FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE SAMPLE. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED CODE AVAILABLE AT THE FACILITY NOR IS IT BEING MANUFACTURED AT THE TIME. HOWEVER, THE DEVICE HISTORY RECORD OF BATCH NUMBER 74L2301434 (NOTED IN SAMPLE EMPTY CARRIER) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY BE RELATED TO THIS COMPLAINT. NO NON-CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED & INSPECTED ACCORDING TO OUR SPECIFICATIONS. IN ADDITION, POST-STERILIZATION RESULTS WERE REVIEWED, AND IT WAS NOTED THAT THE TENSILE TESTS OF THE ATTACHMENTS WERE ACCEPTABLE. COMPLAINTS OF THIS TYPE WILL CONTINUE TO BE MONITORED VIA PERIODIC REVIEWS TO EVALUATE IF ANY TREND EXISTS. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS REPORTED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "ONE CASE INVOLVED THE INABILITY TO SET THE SUTURE. ONE CASE INVOLVED A SUTURE CUT, AND THE NEEDLE AND THE THREAD REMAINED INSIDE THE PATIENT TEMPORARILY, BUT IT WAS ABLE TO PULL OUT". NO PATIENT HARM OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "ONE CASE INVOLVED THE INABILITY TO SET THE SUTURE. ONE CASE INVOLVED A SUTURE CUT, AND THE NEEDLE AND THE THREAD REMAINED INSIDE THE PATIENT TEMPORARILY, BUT IT WAS ABLE TO PULL OUT". NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297274 ABSORBABLE SUTURES DEKLENE MAXX POLYPROPELENE NON TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown