BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4120892 · Received September 11, 2014

    Report

    Report Number
    4120892
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 11, 2014
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CORE BREAST BIOPSY PROCEDURE, THE SUCTION CANISTER IMPLODED, CAUSING BLOOD SPATTER TO THE EQUIPMENT AND WALLS OF PROCEDURE ROOM. IT DID NOT SPLATTER ON PATIENT OR STAFF. THE STAFF AND PHYSICIAN CHECKED SET-UP AND ALL LOOKED APPROPRIATE- CANISTER WAS REPLACED AND PROCEDURE COMPLETED. A SECOND PATIENT WAS BROUGHT INTO ROOM AFTER SETUP CHANGED. THE NEW CANISTER IMPLODED AGAIN. NEW CANISTER REPLACED AND PROCEDURE COMPLETED WITH INCIDENT.HOLOGIC AND BEMIS NOTIFIED. HOLOGIC REMOVED HOLOGIC/SUROS SYSTEM AND PROVIDED A LOANER UNIT. A NEW VENDOR FOR CANISTERS HAVE BEEN OBTAINED. WE WILL RELEASE CANISTERS TO BEMIS ON REQUEST FOR EVALUATION. HAVE REQUESTED RESULTS OF TESTING ALSO FROM HOLOGIC.======================MANUFACTURER RESPONSE FOR SUCTION CANISTER, HYDROPHOBIC 800 CC CANISTER- DISPOSABLE (PER SITE REPORTER)======================

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563313 * BOTTLE, COLLECTION, VACUUM KDQ BEMIS MFG. CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR STEM (B)(6)- INSTALLLED (B)(6)2005| STEREOTACTIC BREAST BIOPSY SYSTEM EVIVA DISPOSABLE| BIOPSY DEVICE & HOLOGIC/SUROS ATEC PEARL BIOPSY SY