BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN QUICK

    MDR report key: 14462244 · Received May 20, 2022

    Report

    Report Number
    3003639970-2022-00201
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    January 12, 2022
    Report Date
    May 20, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CODE NOT REPORTED BUT PROBABLE PMA/510(K) NUMBER: K171001. ANALYSIS AND RESULTS: NO INFORMATION REGARDING THE CODE USED, ONLY THAT WAS A MONOSYN QUICK SUTURE OF THE BATCH 121217. IN CONSEQUENCE, THE BATCH MANUFACTURING RECORDS COULD NOT BE REVIEWED. WITHOUT CLOSED SAMPLES AND/OR DEFECTIVE SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. MOREOVER, THE BATCH MANUFACTURING RECORDS CANNOT BE REVIEWED EITHER. 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. 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 QUICK SUTURE. THE CLIENT REPORTED THAT MEANWHILE A LAPAROSCOPIC REPAIR OF A RIGHT INGUINAL HERNIA WAS BEING PERFORMED IN THE GENERA SURGERY DEPARTMENT AT (B)(6) HOSPITAL THE THREAD AND THE NEEDLE OF THE SUTURE WERE FOUND DETACHED AND THE THREAD WAS BROKEN INTO 4 PIECES. THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539960 MONOSYN QUICK SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. 121217

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male