BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILENE 3/0 (2) 45CM DSMP24 (M) RCP

    MDR report key: 18578716 · Received January 25, 2024

    Report

    Report Number
    3003639970-2024-00031
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Report Date
    January 25, 2024
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAW
    PMA / PMN Number
    K133890
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF INVESTIGATION: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED INTO THE (B)(6) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. BATCH MANUFACTURING RECORD: 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. NEEDLE ATTACHMENT STRENGTH RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 1.51 KGF IN AVERAGE AND 1.37 KGF IN MINIMUM AND FULFILLED THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.69 KGF IN AVERAGE AND 0.35 KGF IN MINIMUM. CONCLUSION ROOT CAUSE ANALYSIS: IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE AS NO SAMPLES ARE RECEIVED. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE, AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. CORRECTIVE MEASURES: ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH OPTILENE SUTURE. THE CLIENT REPORTED THAT HE HAS A PROBLEM WITH ITEM (B)(6) WITH BATCH 123294 IN THAT THE THREAD IS NOT FIRMLY ATTACHED TO THE NEEDLE. THE THREAD HAS ALREADY FALLEN OFF IN SEVERAL BLISTERS WHEN THE CUSTOMER GRIPS THE NEEDLE WITH THE NEEDLE HOLDER. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122820 OPTILENE 3/0 (2) 45CM DSMP24 (M) RCP OTHER SUTURE GAW B. BRAUN SURGICAL, S.A. C3090656 123294

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown