BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML

    MDR report key: 7371843 · Received March 26, 2018

    Report

    Report Number
    3003639970-2018-00191
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Report Date
    June 4, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: EVALUATION ON-GOING H3 OTHER TEXT : DEVICE NOT RETURNED

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: AUSTRALIA. SKIN GLUE WAS ALSO INTRODUCED WITH GOOD RESPONSE FROM THE RADIOLOGISTS. NO FEEDBACK FROM CANCER DAY UNIT IN REGARDS TO POST OPERATIVE CARE. PORT WAS ACCESSED AT TIMES IMMEDIATELY AFTER INSERTION AND ALCOHOLIC CLEANING USED AND APPEARED TO BE CONTRADICTED TO WOUND HEALING. GLUE HAS BEEN CASED AND RETURNED TO DOUBLE SUTURING AS WOUND SHOULD BE LEFT FOR 7 DAYS.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: NO SAMPLES ARE AVAILABLE ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED (B)(4) UNITS IN THE MARKET. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. THE INFORMATION RECEIVED SUGGESTS THAT THE USE OF AN ALCOHOLIC CLEANING SOLUTION MAY BE CONTRADICTED WITH THE WOUND HEALING. PLEASE REFER TO THE INSTRUCTIONS FOR USE OF THE PRODUCT: IN "PRECAUTIONS" SAYS (...) THE AREAS TO BE JOINED SHOULD BE AS DRY AS POSSIBLE. MOISTURE MAY ACCELERATE HISTOACRYL POLYMERIZATION AND MIGHT AFFECT WOUND CLOSURE RESULTS. ANY REMAINING OF TOPICAL MEDICATIONS/ANAESTHETICS MUST BE REMOVED PRIOR TO APPLICATION. IN THE "WARNINGS" SAYS (...) HISTOACRYL SHOULD NOT BE APPLIED TO WET OR BLEEDING WOUNDS. EXCESS MOISTURE (SUCH AS WATER OR ALCOHOL) OR BLOOD PRESENCE, MAY ACCELERATE POLYMERIZATION IN THE GENERATION OF EXCESS HEAT. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212548 HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050052 217254N3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other