BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET WITH T-CONN. SL

    MDR report key: 2313498 · Received October 14, 2011

    Report

    Report Number
    9613251-2011-00212
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 16, 2011
    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

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. REPRESENTATIVE DEVICES FROM THE SAME LOT WERE 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 80 FPA AND HAS A 510K OF K052722. 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 A LEAK; SUBSEQUENTLY BLOOD LOSS WAS NOTED. THE TUBING SET WAS BEING USED TO DELIVERY UNSPECIFIED ANESTHETIC MEDICATIONS IV PUSH. AFTER APPROX ONE HOUR IN USE, IT WAS REPORTED THAT SOLUTION LEAKED FROM A SPLIT IN THE TUBING, PROXIMAL TO THE T-ADAPTER OF THE TUBING SET. AN UNSPECIFIED VOLUME OF BLOOD LOSS WAS NOTED. REPORTEDLY, THE RESEAL STOPPER OF THE T-ADAPTER WAS ACCESSED AN UNSPECIFIED NUMBER OF TIMES WITH AN UNSPECIFIED SYRINGE PRIOR TO THE LEAK. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET WITH T-CONN. SL UNK FPA HOSPIRA LTD. NA 02493NY

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR UNSPECIFIED SYRINGE: MFR UNK