BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 3/0 (2) 75CM HS21 (M) RCP

    MDR report key: 9452577 · Received December 11, 2019

    Report

    Report Number
    3003639970-2019-00875
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Report Date
    December 11, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K133890. INVESTIGATION: SAMPLES RECEIVED: 45 UNOPENED RACEPACKS. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME REFERENCE-BATCH. WE MANUFACTURED 540 UNITS OF THIS CODE-BATCH. THERE ARE 36 UNITS IN OUR STOCK THAT HAVE BEEN BLOCKED. SEWING TEST ON ARTIFICIAL SKIN TISSUE HAS BEEN CONDUCTED WITH SOME CLOSED SAMPLES RECEIVED AND FRAYING/DAMAGED SURFACE APPEARS IN SOME UNITS WHEN PULLING THE THREAD THROUGH THE TISSUE (SEE PICTURE ENCLOSED AFTER CONDUCTING SEWING TEST). REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL THE B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE FAILURE IN SOME OF THE SAMPLES RECEIVED. ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREAD IS FRAYING DURING SURGERY. THE REPORTER INDICATED THAT DURING CARPAL TUNNEL PROCEDURES ON SUBCUTANEOUS AND/OR SKIN CLOSURE THE SUTURE THREAD FRAYS. PER THE REPORTER, THIS IS NOT THE FIRST TIME THAT THE FRAYING OCCURS. PATIENT DATA IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243624 OPTILENE 3/0 (2) 75CM HS21 (M) RCP OTHER SUTURE GAW B.BRAUN SURGICAL SA C3090461 119246

    Patients

    Seq Age Sex Outcome Treatment
    1