BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 5/0 (1) 70CM HR17 (M).RCP

    MDR report key: 17963527 · Received October 19, 2023

    Report

    Report Number
    3003639970-2023-00340
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Report Date
    October 19, 2023
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS AND RESULTS: THE INVOLVED BATCH IS NOT KNOWN. THE POSSIBLE BATCHES ARE: 122073,122163,122172,122194 AND 122211. THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE POSSIBLE BATCHES. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) OF THE BATCH 122073, (B)(4) OF THE BATCH 122163, (B)(4) OF THE BATCH 122172, (B)(4) OF THE BATCH 122194, AND (B)(4) OF THE BATCH 122211. THERE ARE NO UNITS IN STOCK OF ANY OF THEM. WE HAVE ONLY RECEIVED A PICTURE SHOWING A THREAD STILL WOUND ON THE PACK AND THE NEEDLE IS MISSING. HOWEVER, WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REVIEWED THE BATCH MANUFACTURING RECORDS, THERE ARE NO INCIDENCES RELATED TO THIS ISSUE IN ANY OF THE POSSIBLE BATCHES AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. NEEDLE ATTACHMENT STRENGTH RESULTS BEFORE RELEASING THE PRODUCT WERE 0.53 KGF IN AVERAGE AND 0.27 KGF IN MINIMUM FOR THE BATCH 122163, 0.70 KGF IN AVERAGE AND 0.58 KGF IN MINIMUM FOR THE BATCH 122172, 0.93 KGF IN AVERAGE AND 0.72 KGF IN MINIMUM FOR THE BATCH 122194, 0.80 KGF IN AVERAGE AND 0.55 KGF IN MINIMUM FOR THE BATCH 122211 AND FULFILLED THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP REQUIREMENTS: 0.23 KGF IN AVERAGE AND 0.11 KGF IN MINIMUM). FINAL CONCLUSION: IN SPITE OF RECEIVING A PICTURE SHOWING 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. WE REGRET ANY INCONVENIENCE THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. 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 MONOSYN SUTURE. THE CLIENT REPORTED THAT THE THREAD WAS WITHOUT NEEDLE. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077862 MONOSYN VIOLET 5/0 (1) 70CM HR17 (M).RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. C2022003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown