BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOCATH-T 20G 1-1/4IN

    MDR report key: 2087942 · Received March 3, 2011

    Report

    Report Number
    3005515211-2011-00002
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 2, 2011
    Manufacturer
    AMSINO MED CO LTD, CONTRACT MFR FOR HOSPIRA INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. (B)(4). THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FOZ AND IS PRE-AMENDMENT 510K. THE INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN REC'D. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A SEPARATION. THE CATHETER WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, "THE CATHETER BROKE AWAY FROM THE LUER LOCK PART OF THE NEEDLE." THE REMAINING PIECE OF CATHETER WAS REMOVED FROM THE VEIN WITH "TWEEZERS." 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 ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOCATH-T 20G 1-1/4IN UNK FOZ AMSINO MED CO LTD, CONTRACT MFR FOR HOSPIRA INC. NA 59203KY

    Patients

    Seq Age Sex Outcome Treatment
    1