BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL TISSUE ADHES.TRNS 0.5ML

    MDR report key: 7531880 · Received May 22, 2018

    Report

    Report Number
    3003639970-2018-00289
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    December 22, 2017
    Report Date
    May 18, 2018
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: NONE, NO SAMPLES AVAILABLE. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH (B)(4) UNITS WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. THERE ARE NO UNITS IN STOCK IN WAREHOUSE. REVIEWED THE BATCH MANUFACTURING RECORDS. THIS PRODUCT HAD TWO DEVIATIONS NEVERTHELESS, ANY OF THEM ARE RELATED TO THE ISSUE OF THIS COMPLAINT AND THE RESULTS DURING THE PROCESS FULFILL THE OEM REQUIREMENTS. FINAL CONCLUSION: WITHOUT ANY CLOSED SAMPLES A STUDY CAN NOT BE PERFORMED TO SEE IF THE AFFECTED PRODUCT DOES NOT FULFILL THE OEM REQUIREMENTS. NOTE IS TAKEN OF THIS INCIDENT AND IF ANY SAMPLES ARE RECEIVED IN THE FUTURE, THE CASE WILL BE RE-OPENED AND ANALYZED. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE. THIS REPORT IS BEING SUBMITTED LATE DUE TO MIS-INTERPRETATION OF 2 YEAR PRESUMPTION ACKNOWLEDGEMENT AND AGREEMENT BY FDA. ONCE ISSUE WAS IDENTIFIED, RETROSPECTIVE REVIEW OF COMPLAINTS WAS COMPLETED FROM TIME OF 2 YEAR PRESUMPTION IMPLEMENTATION TO PRESENT. ALL REPORTS IDENTIFIED ARE BEING REPORTED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: TAIWAN. THE OUTER BOX WAS INTACT WITHOUT SQUEEZING BY OTHER FORCE, BUT WHEN THE USER UNPACKED IT, THERE'S HISTOARYL ON THE SURFACE OF THE UNOPENED AMPOULE. AMPOULE LEAKAGE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375431 HISTOACRYL TISSUE ADHES.TRNS 0.5ML TISSUE ADHESIVES MPN 1050060 217322N1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other