BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN UNDYED 3/0 (2) 70CM DS24 (M) RCP

    MDR report key: 23165498 · Received September 29, 2025

    Report

    Report Number
    3003639970-2025-00516
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    August 26, 2025
    Report Date
    November 7, 2025
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SUMMARY OF INVESTIGATION: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE NOT RECEIVED ANY SAMPLE. WITHOUT CLOSED SAMPLES AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. AS STATED IN THE INSTRUCTION FOR USE OF THE PRODUCT: 'CARE SHOULD BE TAKEN TO AVOID DAMAGING THE NEEDLE WHEN USING THE SUTURE MATERIAL. ALWAYS GRASP THE NEEDLE IN A SECTION 1/3 TO ½ OF THE DISTANCE FROM THE FIBBER ATTACHMENT END TO THE NEEDLE POINT, BUT NEVER DIRECTLY AT THE END WHERE THE FIBBER IS ATTACHED OR AT THE POINT OF THE NEEDLE. GRASPING THE NEEDLE AT THE AREA OF THE POINT COULD IMPAIR THE PENETRATION PERFORMANCE AND CAUSE A FRACTURE OF THE NEEDLE. GRASPING THE NEEDLE CLOSE TO THE FIBBER ATTACHMENT END COULD CAUSE BENDING AND BREAKAGE OF THE NEEDLE. RESHAPING NEEDLES MUST BE AVOIDED AND MAY RESULT IN A LOSS OF THEIR STRENGTH AND RESISTANCE TOWARDS BENDING AND BREAKING.' BATCH MANUFACTURING RECORD: REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILLED USP/EUROPEAN PHARMACOPOEIA AND B. BRAUN SURGICAL REQUIREMENTS. NEEDLE PENETRATION PERFORMANCE RESULTS (AVERAGE 1ST PENETRATION) OF NEEDLES TESTED OF THE RAW MATERIAL BATCHES USED IN THIS PRODUCT DURING PRODUCTION WERE 0.389 N, 0.423 N, 0.342 N, 0.412 N, 0.340 N AND 0.356 N AND FULFILLED THE SPECIFICATION (<0.480 N). WE HAVE ALSO REVIEWED THE COMPLAINT HISTORY RECORD, AND THERE ARE NO PREVIOUS COMPLAINTS IN ANY OF THE PRODUCTS MANUFACTURED WITH THE SAME NEEDLE RAW MATERIAL BATCHES AS THE USED IN THIS PRODUCT. CONCLUSION ROOT CAUSE ANALYSIS: IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE AS NO SAMPLES HAVE BEEN 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 MONOSYN SUTURE. THE CLIENT REPORTED THAT THE NEEDLE IS NOT SHARP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469678 MONOSYN UNDYED 3/0 (2) 70CM DS24 (M) RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. C2023215 350681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown