BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN VIOLET 0 (3,5) 70CM HS26S (M)RCP

    MDR report key: 17123991 · Received June 14, 2023

    Report

    Report Number
    3003639970-2023-00195
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 29, 2023
    Report Date
    June 14, 2023
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 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. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF ANY OF THE TWO CODE BATCHES. (B)(4) UNITS OF C2022243-122394 WERE MANUFACTURED. THERE ARE 24 UNITS BLOCKED IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED AN OPEN BOX LABELLED AS 'MONOSYN 0 HS26S; CODE: C2022243; BATCH 122394', WHICH CONTAINS 8 UNOPENED RACE-PACKS OF THE SAME CODE-BATCH AND 4 UNOPENED RACE-PACKS OF ANOTHER CODE-BATCH (MONOSYN 4/0 DS19; CODE: 2022504; BATCH: 122393). WE HAVE OPENED THE 4 CLOSED RACE-PACKS AND CORRESPOND TO THE PRODUCT LABELED IN THE RACE-PACKS. AFTER THE INVESTIGATION IT HAS BEEN DETERMINED THAT BOTH PRODUCTS WERE PACKED ONE AFTER THE OTHER IN THE PACKAGING MACHINE AND THAT NO CLEAN LINE WAS PERFORMED BETWEEN THE ORDERS. WE CANNOT KNOW THE NUMBER OF RACE-PACKS INVOLVED BUT TAKING INTO CONSIDERATION THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED, WE CONSIDER THAT ONLY THE 4 RACE-PACKS WERE AFFECTED. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD AN INCIDENCE NOT RELATED TO THIS ISSUE AND WAS RELEASED FULFILLING USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. REMARKS: WE HAVE INFORMED THE PERSONNEL INVOLVED OF THIS ISSUE. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLES RECEIVED DO NOT FULFIL THE SPECIFICATIONS OF THE EUROPEAN PHARMACOPOEIA/B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. 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 MONOSYN SUTURE. THE CLIENT (VETERINARIAN) REPORTED THAT IN A PRODUCT BOX OF MONOSYN USP 0 HS26S (REFERENCE: C2022243; LOT NUMBER 122394) FOUND 4 UNITS OF ANOTHER PRODUCT REFERENCE (MONOSYN 4/0 DS19; REFERENCE: 2022504 AND LOT NUMBER: 122393).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972878 MONOSYN VIOLET 0 (3,5) 70CM HS26S (M)RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE GAM B. BRAUN SURGICAL, S.A. C2022243 122394

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown