BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 8957164 · Received September 3, 2019

    Report

    Report Number
    3003639970-2019-00626
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Report Date
    September 30, 2019
    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

    MANUFACTURING EVALUATION: ANALYSIS AND RESULTS: THERE ARE PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH REGARDING THE SAME ISSUE. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL WAREHOUSE. WE HAVE RECEIVED THREE OPEN SAMPLES. THE AMPOULES OF THE OPEN SAMPLES RECEIVED HAVE BEEN OPTICALLY EVALUATED AND A DEFECT IN THE SEALING BAR OF THE AMPOULE (YELLOW BAR AT THE BOTTOM OF THE AMPOULE) WAS FOUND. THE LEAKAGE OF THE GLUE OCCURS AT THIS POINT. REVIEWED THE BATCH MANUFACTURING RECORD OF THIS PRODUCT, THERE ARE NO INCIDENCES RELATED TO THIS ISSUE, AND THE PRODUCT 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.

    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. K111959. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE HISTOACRYL. THE PRODUCTS WERE FOUND TO BE LEAKING. THIS WAS FOUND IN THE OPERATING ROOM ON 7 PACKETS SINCE (B)(6) 2019, AND THEY WERE NOT USED ON PATIENTS. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751618 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 218353N3

    Patients

    Seq Age Sex Outcome Treatment
    1