BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMEND ST 4/0 18''(45CM) HR17 VPL .RCP

    MDR report key: 25077915 · Received May 5, 2026

    Report

    Report Number
    3003639970-2026-00429
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Report Date
    May 5, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: REPORTED DEVICE MARKETED IN THE U.S. ONLY FOR VETERINARY USE, HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. RELATED 510K NUMBER K171001 SUMMARY OF INVESTIGATION: THERE ARE NO PREVIOUS COMPLAINTS ABOUT THIS CODE BATCH WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED 7 CLOSED SAMPLES. TO EVALUATE THE CONFORMITY OF THESE UNITS, WE PERFORMED THE FOLLOWING TESTS: TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. NEEDLE ATTACHMENT STRENGTH RESULTS CONDUCTED ON THE 7 CLOSED SAMPLES RECEIVED ARE 1.15 KGF IN AVERAGE AND 0.58 KGF IN MINIMUM AND FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP): 0.46 KGF IN AVERAGE AND 0.23 KGF IN MINIMUM. BATCH MANUFACTURING RECORD: REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FURTHERMORE, NEEDLE ATTACHMENT RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 0.80 KGF IN AVERAGE AND 0.67 KGF IN MINIMUM AND FULFILLED EP REQUIREMENTS: 0.46 KGF IN AVERAGE AND 0.23 KGF IN MINIMUM. CONCLUSION ROOT CAUSE ANALYSIS: IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE BECAUSE THE CLOSED SAMPLES RECEIVED COMPLY USP/EP AND B. BRAUN SURGICAL REQUIREMENT REGARDING NEEDLE ATTACHMENT STRENGTH. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE CLOSED SAMPLES RECEIVED FULFIL EUROPEAN PHARMACOPOEIA/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. THE CASE IS CONSIDERED NOT CONFIRMED BY EVIDENCE OF THE CLOSED SAMPLES RECEIVED. WE APOLOGISE FOR ANY INCONVENIENCE THAT THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. 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 MONOMEND ST SUTURE. THE CLIENT (VETERINARIAN) REPORTED THAT THEY WENT TO USE A PACK IN THIS BOX AND THERE WAS NOT A NEEDLE CONNECTED TO THE SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219455 MONOMEND ST 4/0 18''(45CM) HR17 VPL .RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. 100523608 1444TD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown