BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOCATH-T 22G 1-1/4

    MDR report key: 1833633 · Received August 17, 2010

    Report

    Report Number
    3005515211-2010-00003
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    June 25, 2010
    Report Date
    July 20, 2010
    Manufacturer
    AMSINO MEDICAL CO., LTD., CONTRACT MFR FOR HOSPIRA INC.
    Product Code
    FOZ
    PMA / PMN Number
    PREAMEN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS EVALUATED. TESTING FOUND THE CATHETER WAS KINKED. A HOLE WAS ALSO NOTED IN THE CATHETER WHERE IT CONNECTS TO THE HUB. THE MOST PROBABLE CAUSE WAS DAMAGE FROM HANDLING AND NEEDLE USAGE. THE INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL; (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BLOOD LOSS. IT WAS REPORTED THAT DURING AN MRI, THE CATHETER WAS PLACED IN THE PT'S FEMORAL VEIN UNDER GENERAL ANESTHESIA. THE CATHETER PLACEMENT WAS REPORTED AS DIFFICULT. THE PT HAD BEEN RECEIVING UNSPECIFIED IV FLUID PRIOR TO THE PROCEDURE; HOWEVER, THE IV FLUIDS WERE BEING HELD PENDING IF THE PT WAS ABLE TO TAKE ORAL FLUID PRIOR TO THE CATHETER REMOVAL. AT AN UNSPECIFIED TIME AFTER THE CATHETER WAS PLACED, THE NURSE WAS CALLED TO THE BEDSIDE. AT THIS TIME, BLOOD WAS NOTED UNDERNEATH THE OCCLUSIVE DRESSING THAT COVERED THE INSERTION SITE. THE VOLUME OF BLOOD LOSS WAS UNSPECIFIED. AFTER CLEANSING THE INSERTION SITE AND FLUSHING THE CATHETER WITH NORMAL SALINE, THE NURSE NOTED A KINK IN THE CATHETER AND LEAKAGE FROM A HOLE NEAR THE HUB. IT WAS REPORTED THAT THE NURSE REMOVED THE CATHETER AND PRESSURE WAS APPLIED TO THE AREA. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOCATH-T 22G 1-1/4 80FOZ FOZ AMSINO MEDICAL CO., LTD., CONTRACT MFR FOR HOSPIRA INC. NA UNKKY

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO