BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 3/0 (2) 70CM DRC22 (M)RCP

    MDR report key: 8866740 · Received August 6, 2019

    Report

    Report Number
    3003639970-2019-00589
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Report Date
    August 6, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K011375. MANUFACTURING SITE EVALUATION: ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THIS CODE-BATCH REGARDING OTHER ISSUE (NEEDLE DETACHMENT). THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED 28 CLOSED SAMPLES AND 1 PIECE OF THREAD BROKEN WITHOUT PACKAGING. HOWEVER, CHECKING THE PIECE OF THREAD BROKEN RECEIVED WE HAVE NOTICED THAT CORRESPONDS TO A MULTIFILAMENT SUTURE INSTEAD OF MONOFILAMENT SUTURE, AS IT IS MONOSYN SUTURE. TIGHTNESS TEST TO THE CLOSED SAMPLES RECEIVED HAS BEEN PERFORMED AND THE UNITS ARE TIGHT. WE HAVE TESTED THE KNOT PULL TENSILE STRENGTH OF THE CLOSED SAMPLES RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA (EP). 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. FINAL CONCLUSION: ALTHOUGH THE RESULTS OF THE CLOSED SAMPLES RECEIVED FULFIL THE SPECIFICATIONS OF EP/ B. BRAUN SURGICAL SPECIFICATIONS, WE TAKE NOTE OF THIS INCIDENCE IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE MONOSYN SUTURES. DURING AN UNSPECIFIED VETERINARY SURGERY, THE SUTURE BROKE. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657354 MONOSYN VIOLET 3/0 (2) 70CM DRC22 (M)RCP SYNTHETIC ABSORBABLE MONOFILAR GAM B.BRAUN SURGICAL SA C2022355 118295

    Patients

    Seq Age Sex Outcome Treatment
    1