BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 4/0(1,5)70CM DS19 (M) RCP

    MDR report key: 14040175 · Received April 7, 2022

    Report

    Report Number
    3003639970-2022-00126
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Report Date
    June 1, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    K011375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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

    ANALYSIS AND RESULTS: 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 STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE ONLY RECEIVED A PICTURE FROM THE CUSTOMER SHOWING A UNIT OF MONOSYN VIOLET 4/0(1,5)70CM DS19 (M) RCP; REFERENCE C2022204 AND BATCH 121453 THAT THE SUPPORT AND SUTURE INSIDE IS MONOSYN VIOLET 2/0 70CM HR30 (CODE 2022036 AND BATCH 121454). ACCORDING TO THE CUSTOMER INFORMATION RECEIVED, ONLY (B)(4) UNIT IN A BOX WAS FOUND WITH THIS ISSUE OF THE (B)(4) BOXES RECEIVED. UPON INTERNAL INVESTIGATION, THIS MIX-UP TOOK PLACE BY HUMAN ERROR DURING MANUFACTURING PROCESS. BOTH PRODUCTS WERE PACKED ONE AFTER THE OTHER, BUT THE CURRENT SECURITY SYSTEM OF THE MACHINE DOES NOT ALLOW TO MIX-UP IN THE MANUFACTURING ORDERS. THE VISION SYSTEM SORTS OUT THE NON-CONFORMING UNITS. PROBABLY, THE OPERATOR BY MISTAKE RECOVERED THIS UNIT REJECTED AND DID NOT CHECK THAT THE PRODUCT INSIDE DOES NOT MATCH WITH THE DESCRIPTION OF THE PACKAGE. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE PICTURE RECEIVED SHOWS A UNIT THAT DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE FAILURE IN THE PICTURE RECEIVED. 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: WE HAVE OPENED AN INTERNAL NON-CONFORMITY AND A CORRECTIVE ACTION IN ORDER TO AVOID THIS KIND OF INCIDENTS IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH MONOSYN SUTURE. THE CLIENT (VETERINARIAN) REPORTED THAT IN A BOX OF CODE C0022204 (MONOSYN VIOLET 4-0 DS19 70 CM) EVERYTHING WAS LABELED AS 4/0, BUT THEY FOUND THAT THE CONTENT WAS A 2/0 THREAD. IN ADDITIONAL INFORMATION RECEIVED, THE CUSTOMER SAID THERE IS ONLY ONE THREAD THAT WAS PACKAGED INCORRECTLY. FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913405 MONOSYN VIOLET 4/0(1,5)70CM DS19 (M) RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. C2022204 121453

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown