BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET WITH T-CONN.SL

    MDR report key: 1588146 · Received January 21, 2010

    Report

    Report Number
    9613251-2010-00002
    Event Type
    Malfunction
    Date Received
    January 21, 2010
    Date of Event
    January 1, 2009
    Report Date
    December 23, 2009
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    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

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC (B)(4). THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K052722. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A CRACK; SUBSEQUENTLY, BLOOD LOSS WAS NOTED. THE TUBING WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, BLOOD WAS NOTED TO BE LEAKING FROM A CRACK IN THE LOCKING T-SPIN COLLAR ON THE DISTAL END OF THE TUBING SET. INFORMATION WAS REQUESTED FROM THE CUSTOMER CONTACT REGARDING THE EVENT DATE, THE SOLUTION THAT WAS INFUSING, THE TYPE OF ACCESS THAT THE T-CONNECTOR WAS CONNECTED TO, ACTIONS TAKEN AS A RESULT OF THE EVENT, THE VOLUME OF BLOOD LOSS, IF MEDICAL INTERVENTIONS WERE REQUIRED, IF THERE WAS A DELAY IN THERAPY CRITICAL TO THIS PATIENT, AND THE PATIENT'S DIAGNOSIS. NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET WITH T-CONN.SL UNK FPA HOSPIRA LTD. NA 69004NY

    Patients

    Seq Age Sex Outcome Treatment
    1