BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML

    MDR report key: 5925036 · Received September 2, 2016

    Report

    Report Number
    2916714-2016-00718
    Event Type
    Malfunction
    Date Received
    September 2, 2016
    Date of Event
    July 8, 2016
    Report Date
    November 28, 2016
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE REGISTERED WITHIN THE U.S. (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: BRAZIL. THE CUSTOMER REPORTED THAT THEY ACQUIRED 8 BOXES OF PRODUCT AND 1 OF THE BOXES ARRIVED WITHOUT A NATIONALIZATION LABEL.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: NONE. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. THERE ARE NO UNITS IN OUR STOCK. RECEIVED SOME PICTURES SHOWING ONE BOX WITHOUT THE ADDITIONAL LABEL. ACCORDING TO THE INFORMATION RECEIVED, THE CUSTOMER RECEIVED EIGHT BOXES AND ONLY ONE OF THEM WITHOUT THE ADDITIONAL LABEL. THIS MISTAKE WAS PROBABLY PRODUCED AT THE MOMENT OF PREPARING THE SHIPMENT IN THE WAREHOUSE. THE INVOLVED PERSONNEL IN THE PACKAGING STEP DID NOT NOTICE THAT ONE BOX WAS NOT LABELED. TAKING INTO ACCOUNT THE REST OF THE BOXES THAT THE CUSTOMER HAS RECEIVED HAVE THE ADDITIONAL LABEL, AND THAT THERE ARE NO OTHER CUSTOMER COMPLAINTS CONCERNING THIS ISSUE FOR THIS CODE-BATCH, THIS IS CONSIDERED AN ACCIDENTAL AND ISOLATED INCIDENT. FINAL CONCLUSION: WE CONCLUDE THAT THE COMPLAINT IS JUSTIFIED. NOTE IS TAKEN OF THIS INCIDENT IN ORDER TO ASSESS IF NEW OR ADDITIONAL ACTIONS ARE NEEDED. CORRECTIVE/PREVENTIVE ACTIONS: THIS COMPLAINT WILL BE INCLUDED IN THE ANALYSIS OF TRENDING, AND CORRECTIVE ACTION WILL BE OPEN IF APPLIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577484 HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050052 216051N3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other