BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 9152418 · Received October 3, 2019

    Report

    Report Number
    3003639970-2019-00673
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Report Date
    January 13, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: (B)(4) OPEN POUCHES WITH UNOPENED AMPOULES. ANALYSIS AND RESULTS: THERE IS A PREVIOUS COMPLAINT OF THIS CODE BATCH REGARDING THE SAME ISSUE. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE (B)(4) 20 UNITS BLOCKED IN STOCK IN B. BRAUN SURGICAL WAREHOUSE. WE HAVE RECEIVED 5 OPEN POUCHES (5 CLOSED AMPOULES) SHOWING AMPOULE LEAKAGE. THE AMPOULES RECEIVED HAVE 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 AN INCIDENCE NOT RELATED TO THIS ISSUE AND WAS RELEASED FULFILLING B. BRAUN SURGICAL SPECIFICATIONS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF THE SAMPLES RECEIVED DO NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF FAILURE IN 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. A CAPA HAS BEEN INITIATED.

    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. K111959. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED. THE REPORTER INDICATED THAT AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE GLUE LEAKED INTO THE BAG. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946521 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 218352N3

    Patients

    Seq Age Sex Outcome Treatment
    1