BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 3/0 (2) 70CM HR17 (M).RCP

    MDR report key: 18665790 · Received February 8, 2024

    Report

    Report Number
    3003639970-2024-00050
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    January 29, 2024
    Report Date
    March 4, 2024
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY OF INVESTIGATION: THERE ARE NO PREVIOUS COMPLAINTS FOR THE INVOLVED CODE AND BATCHES 123081, 123181, 132439 AND 13243A. THERE IS ONE PREVIOUS COMPLAINT RELATED A PACKAGING ISSUE FOR THE INVOLVED CODE AND BATCH 123222. WE MANUFACTURED (B)(4) UNITS OF BATCH 123081; (B)(4) UNITS OF BATCH 123181; (B)(4) UNITS OF BATCH 123222; (B)(4)UNITS OF BATCH 132439 AND(B)(4)UNITS OF BATCH 13243A. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL WAREHOUSE OF ANY OF THE POSSIBLE CODE-BATCHES. WE HAVE RECEIVED AN OPEN AND UNUSED SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD (THREAD IS NOT WOUND ON THE PACK). HOWEVER, WITHOUT CLOSED SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. BATCH MANUFACTURING RECORD: REVIEWED THE POSSIBLE BATCHES MANUFACTURING RECORDS, BATCHES 123081, 123181, 132439 AND 123222 HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. REVIEWED THE BATCH 13243A MANUFACTURING RECORD, THIS PRODUCT HAD NO INCIDENCES RELATED TO THIS ISSUE AND WAS RELEASED FULFILLING USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. CONCLUSION ROOT CAUSE ANALYSIS: THE ROOT CAUSE CANNOT BE DETERMINED AS NO CLOSED SAMPLES HAVE BEEN RECEIVED AND ONLY ONE OPEN SAMPLE RECEIVED. FINAL CONCLUSION: DESPITE RECEIVING A DEFECTIVE SAMPLE, WITHOUT CLOSED SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. CORRECTIVE MEASURES: 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. 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.

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH MONOSYN SUTURE. THE CLIENT REPORTED THAT THE NEEDLE AND THREAD WERE NOT CONNECTED. THE INVOLVED LOT NUMBER IS NOT KNOWN. LIST OF LOT NUMBERS SUPPLIED TO THE END CUSTOMER IN THE LAST SIX MONTHS (B)(6) 2023 TO (B)(6) 2024: 123081, 123181, 123222, 132439 AND 13243A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305996 MONOSYN VIOLET 3/0 (2) 70CM HR17 (M).RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. C2022005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown