BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 0 (3.5) 5X70CM

    MDR report key: 9643754 · Received January 29, 2020

    Report

    Report Number
    3003639970-2020-00025
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Report Date
    March 19, 2020
    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 · 0

    INVESTIGATION: SAMPLES RECEIVED: (B)(4) UNOPENED ALUMINUM POUCH. 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 AN UNUSED SAMPLE. THE ALUMINUM PACK (FIRST PACK) IS CLOSED AND A PIECE OF PLASTIC FILM OF THE SECOND PACK IS ATTACHED IN THE 4TH SEALING AREA AS CAN BE SEEN IN THE ENCLOSED PICTURE. THE FIRST PACK IS SEALED TO THE SECOND PACK IN THE SEALING AREA, THIS IS DUE AN ACCIDENTAL EFFECT OF THE WELDING MACHINE AND THIS UNIT WAS NOT SORTED OUT BY THE MANUFACTURING PERSONNEL. DUE TO THIS DEFECT, THE PLASTIC FILM OF THE SECOND PACK BREAKS WHEN THE PACK IS OPENED. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. AS THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH, WE CONSIDER THAT THIS IS AN ACCIDENTAL AND ISOLATED UNIT. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLE RECEIVED DO NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLE 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Additional Manufacturer Narrative · 1

    PMA/510K: 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. K031286. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE IS A PACKAGING DEFECT-WELDING. THE REPORTER INDICATED THAT THE SECONDARY PACKAGING IS WELDED ONTO THE STERILE PRIMARY PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106714 SAFIL VIOLET 0 (3.5) 5X70CM SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA C1038447 118372

    Patients

    Seq Age Sex Outcome Treatment
    1