BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 7522943 · Received May 17, 2018

    Report

    Report Number
    3003639970-2018-00279
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Report Date
    May 17, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 4 OPENED POUCHES (UNOPENED AMPOULES WITH LEAKING SIGNS). 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. THE FOUR AMPOULES WITH LEAKAGE HAS BEEN CHECKED AND THE SEALING BAR (YELLOW BAR AT THE BOTTOM OF THE AMPOULE) IS WRONGLY SEALED AND IN CONSEQUENCE THERE IS LEAKAGE. CHECKED THE BATCH MANUFACTURING RECORD AND A DEVIATION WAS FOUND, NEVERTHELESS NOT RELATED TO THIS ISSUE (PACKAGING). THE HISTOACRYL MACHINE FOR FILLING AMPOULES AND PACKAGING THEM INTO THE POUCHES WAS DESIGNED TO DETECT EVERY EMPTY POUCH AND NON CONFORMING AMPOULE. NEVERTHELESS, WE ASSUME SOME ISSUES IN THIS BATCH THAT LET SOME NON CONFORMING UNITS GET RELEASED INTO THE MARKET. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE SAMPLES RECEIVED DO NOT FULFILL THE OEM SPECIFICATIONS, IT IS CONCLUDED THAT THE COMPLAINT IS JUSTIFIED. 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: JAPAN. IT IS WAS REPORTED THAT THE NURSE OPENED THE PLASTIC PACKAGE AND FOUND THE AMPOULE BOTTLE TO BE EMPTY OR THE PRODUCT LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364150 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 216183N2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other