BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HISTOACRYL CLEAR SKIN ADHESIVE (FP)

    MDR report key: 9755064 · Received February 26, 2020

    Report

    Report Number
    3003639970-2020-00125
    Event Type
    Injury
    Date Received
    February 26, 2020
    Report Date
    April 21, 2020
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SAMPLES RECEIVED: (B)(4) OPEN POUCHES (CONTAIN AN UNOPENED AMPOULE EACH ONE). ANALYSIS AND RESULTS: THERE ARE PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL WAREHOUSE. WE HAVE RECEIVED SIX OPEN POUCHES (CLOSED AMPOULES) SHOWING AMPOULE LEAKAGE. THE AMPOULES RECEIVED HAVE BEEN OPTICALLY EVALUATED AND A DEFECT IN THE SEALING BAR OF THE AMPOULES WAS FOUND. THE LEAKAGE OF THE GLUE OCCURS AT THIS POINT.. WE HAVE CONDUCTED A REVIEW OF THE BATCH MANUFACTURING RECORD OF THIS PRODUCT AND NO DEVIATIONS HAVE BEEN FOUND. 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. ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, WE HAVE OPENED A CAPA IN THE SYSTEM IN ORDER TO DETERMINE ROOT CAUSE AND ACTIONS TO CORRECT/PREVENT THIS DEFECT TO HAPPEN. CAPA NUMBER: AK201730130.

    Additional Manufacturer Narrative · 1

    K111959 PMA/510K: 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. WHEN ADDITIONAL INFORMATION/INVESTIGATION RESULTS BECOME AVAILABLE, RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH HISTOACRYL CLEAR SKIN ADHESIVE. THE CUSTOMER REPORTED "WE ARE SEEING MULTIPLE TUBES THAT ARE CLOUDY AND NOT CLEAR." FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221690 HISTOACRYL CLEAR SKIN ADHESIVE (FP) TISSUE ADHESIVES MPN B. BRAUN SURGICAL SA TS1050071FP 219265N1

    Patients

    Seq Age Sex Outcome Treatment
    1