BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL FLEXIBLE PACK 5

    MDR report key: 9693471 · Received February 11, 2020

    Report

    Report Number
    3003639970-2020-00066
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 21, 2020
    Report Date
    February 13, 2020
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT DESCRIPTION: LEAKAGE WAS CONFIRMED BEFORE OPENING THE PACKAGE. PATIENT INFORMATION: NOT APPLICABLE, BEFORE USE. SAMPLES RECEIVED: 1 OPEN POUCHES, UNOPENED AMPOULE. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4). THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL WAREHOUSE. WE HAVE RECEIVED ONE OPEN POUCH (CLOSED AMPOULE) SHOWING AMPOULE LEAKAGE. THE AMPOULE RECEIVED HAS BEEN OPTICALLY EVALUATED AND A DEFECT IN THE SEALING BAR OF THE AMPOULE WAS FOUND. THE LEAKAGE OF THE GLUE OCCURS AT THIS POINT. 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. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF THE SAMPLE RECEIVED DO NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF FAILURE IN 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. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, WE HAVE OPENED A CAPA IN THE SYSTEM IN ORDER TO DETERMINE ROOT CAUSE AND ACTIONS TO CORRECT/PREVENT THIS DEFECT TO HAPPEN. CAPA NUMBER: AK201730130.

    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. K140343. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT, IF APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE HISTOACRYL FLEXIBLE PACK. THE CUSTOMER REPORTED LEAKAGE WAS CONFIRMED BEFORE OPENING THE PACKAGE. THERE IS NO PATIENT INFORMATION PROVIDED AS THE EVENT OCCURRED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156240 HISTOACRYL FLEXIBLE PACK 5 TISSUE ADHESIVES MPN B. BRAUN SURGICAL SA 1051250P 219045N1

    Patients

    Seq Age Sex Outcome Treatment
    1