BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1512458 · Received October 15, 2009

    Report

    Report Number
    9615050-2009-00238
    Event Type
    Malfunction
    Date Received
    October 15, 2009
    Date of Event
    June 1, 2009
    Report Date
    September 15, 2009
    Manufacturer
    HOSPIRA COSTA RICA 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. THE LIST NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER REPORTED TWO POSSIBLE LIST AND LOT NUMBERS 0P317, LOT #751265H AND 0P285, LOT #761115H. THE INTERNATIONAL (B)(4) IS COMPARABLE TO THE DOMESTIC (B)(4). THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K933326. THE INTERNATIONAL (B)(4) IS COMPARABLE TO THE DOMESTIC(B)(4). THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K052052. THE INTERNATIONAL AFFILIATE WAS CONTACTED, AND INFORMATION ON REPROCESSING THE DEVICE WAS REQUESTED. NO RESPONSE HAS BEEN RECEIVED. 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 DISCONNECTION. AN UNSPECIFIED PLUMSET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED CONCENTRATION OF AN UNSPECIFIED SOLUTION. THE SECURE LOCK MALE ADAPTER WAS CONNECTED TO A NEEDLE-FREE ADAPTER. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS REPORTED THAT THE SECURE LOCK MALE ADAPTOR OF THE TUBING SET DISCONNECTED FROM THE NEEDLE-FREE ADAPTOR. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN CRITICAL THERAPY. NO MEDICAL INTERVENTION WAS REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT #H86422-1, (B)(4)| SWAN-LOCK NEEDLE-FREE ADAPTOR, LIST #UNK,