BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOMEND ST 5/0 18''(45)DSMP13(M)VPL.RCP

    MDR report key: 24686675 · Received March 25, 2026

    Report

    Report Number
    3003639970-2026-00353
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Report Date
    March 25, 2026
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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 THREE OPEN SAMPLES: ONE OPEN AND MANIPULATED SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD (WITH ALUMINIUM POUCH AND THE THREAD IS NOT STILL WOUND ON THE PACK BUT THE NEEDLE IS MISSING), ONE OPEN SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD BUT THE THREAD IS BROKEN INTO SMALL PIECES (WITHOUT ALUMINIUM POUCH) AND ONE OPEN AND MANIPULATED SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD (WITH ALUMINIUM POUCH AND THE THREAD IS NOT STILL WOUND ON THE PACK). 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 STRENGTH RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT WERE 0.92 KGF IN AVERAGE AND 0.82 KGF IN MINIMUM AND FULFILLED THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA: 0.23 KGF IN AVERAGE AND 0.11 KGF IN MINIMUM. CONCLUSION ROOT CAUSE ANALYSIS: THE MOST PROBABLE ROOT CAUSE IS THAT THE ATTACHMENT OF THE NEEDLE WAS NOT CORRECTLY DONE AS THE SAMPLES RECEIVED SHOW THAT THE NEEDLE ESCAPED FROM THE THREAD. FINAL CONCLUSION: CONSIDERING THAT THE SAMPLES RECEIVED SHOW THAT THE PRODUCT DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. WE APOLOGIZE FOR ANY INCONVENIENCE THAT THIS ISSUE MAY HAVE CAUSED AND THANK YOU FOR YOUR COLLABORATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH MONOMEND ST SUTURE. THE CLIENT (VETERINARIAN) REPORTED THAT THEY HAD ISSUES WITH THE SUTURE: ONE STRAND DID NOT HAVE A NEEDLE AT ALL IN THE PACKAGING. ONE STRAND HAD A NEEDLE THAT WAS NOT ATTACHED BUT WITHIN THE PACKAGE. THE THIRD HAD A VERY LOOSELY ATTACHED NEEDLE THAT CAME OFF PULLING THE SUTURE OUT OF THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558097 MONOMEND ST 5/0 18''(45)DSMP13(M)VPL.RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. 100523605 123132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown