BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOCATH-T 20G 1-1/4IN

    MDR report key: 3311152 · Received August 6, 2013

    Report

    Report Number
    3005515211-2013-00009
    Event Type
    Malfunction
    Date Received
    August 6, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 8, 2013
    Manufacturer
    AMSINO MEDICAL CO., LTD. (CONTRACT MFR FOR HOSPIRA, CO)
    Product Code
    FOZ
    PMA / PMN Number
    PREAMEN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. 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 PRE-AMENDMENT 510K. THE INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY IN CRITICAL THERAPY FOLLOWING DEVICE BREAKAGE. THE I.V. CATHETER WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION. THE CUSTOMER CONTACT REPORTED THAT AFTER THE NEEDLE WAS REMOVED FROM THE CATHETER, THE CATHETER WAS NOTED TO BE BROKEN AT AN UNSPECIFIED LOCATION. THE CUSTOMER CONTACT REPORTED DELAY OF CRITICAL THERAPY. NO SPECIFIC DETAILS WERE REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE I.V. CATHETER WAS REPLACED AND THE THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368856 ABBOCATH-T 20G 1-1/4IN 80FOZ FOZ AMSINO MEDICAL CO., LTD. (CONTRACT MFR FOR HOSPIRA, CO) NA 23204KY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK