BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOCATH-T 20G 2IN

    MDR report key: 2759316 · Received September 11, 2012

    Report

    Report Number
    3005515211-2012-00074
    Event Type
    Malfunction
    Date Received
    September 11, 2012
    Date of Event
    July 27, 2012
    Report Date
    August 16, 2012
    Manufacturer
    AMSINO MEDICAL CO., LTD., CONTRACT MANUFACTURER FOR HOSPIRA INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FOZ AND IS 510K PREAMENDMENT. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE CATHETER WAS TO BE USED FOR CONTINUOUS ARTERIAL BLOOD PRESSURE MONITORING. THE CUSTOMER CONTACT REPORTED THAT WHILE INSERTING THE CATHETER INTO THE PT'S RIGHT BRACHIAL ARTERY, THE HUB SEPARATED FROM THE CATHETER AND THE TIP OF THE CATHETER REMAINED LODGED IN THE PT'S BRACHIAL ART. THE CUSTOMER CONTACT INDICATED THAT THE ANESTHETIST REMOVED THE TIP OF THE CATHETER FROM THE PT'S BRACHIAL ARTERY. THE CATHETER WAS REPLACED AND THE MONITORING WAS INITIATED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOCATH-T 20G 2IN UNK FOZ AMSINO MEDICAL CO., LTD., CONTRACT MANUFACTURER FOR HOSPIRA INC. NA 11202KY

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR