BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS VIOLET 2/0 (3) 70CM HR26 (M)RCP

    MDR report key: 11997727 · Received June 15, 2021

    Report

    Report Number
    3003639970-2021-00234
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 15, 2021
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    NEW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. UNDER PMA/510(K) NUMBER: K031216. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH OF 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 A PICTURE THAT SHOWS A SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD AND THE THREAD IS STILL WOUND ON THE PACK. HOWEVER, WITHOUT CLOSED SAMPLES A PROPER ANALYSIS CANNOT BE PERFORMED. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILS USP/EP AND BBS REQUIREMENT. CONSIDERING THAT NO OTHER CUSTOMER COMPLAINTS HAVE BEEN RECEIVED CONCERNING THIS ISSUE FOR THIS CODE-BATCH, WE CONSIDER THAT THIS IS AN ISOLATED UNIT AND CLAIM IS JUSTIFIED, BUT THE WHOLE BATCH IS CORRECT. FINAL CONCLUSION: IN SPITE OF RECEIVING A PICTURE SHOWING A DEFECTIVE SAMPLE, WITHOUT SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. 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 · 1

    IT WAS REPORTED AN ISSUE WITH MONOPLUS SUTURE. THE CLIENT (VETERINARIAN) REPORTED THAT THE NEEDLE DETACHED FROM SUTURE WHEN OPENED THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. NO MORE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901329 MONOPLUS VIOLET 2/0 (3) 70CM HR26 (M)RCP SYNTHETIC ABSORBABLE MONOFILAR SUTURE NEW B. BRAUN SURGICAL, S.A. C2024026 120205

    Patients

    Seq Age Sex Outcome Treatment
    1