BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET 7IN REM CLAVE SITE NDEHP

    MDR report key: 3850883 · Received February 12, 2014

    Report

    Report Number
    9613251-2014-00028
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 9, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. A REP DEVICE FROM AN UNSPECIFIED LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. THE SECURE LOCK MALE ADAPTER OF THE EXTENSION TUBING SET WAS CONNECTED TO THE PT'S IV ACCESS SITE FOR A DELIVERY OF AN UNSPECIFIED MEDICATION. AT AN UNSPECIFIED TIME, THE CUSTOMER CONTACT REPORTED THAT A MINIMAL AMOUNT OF SOLUTION LEAKED FROM THE REMOVABLE CLAVE PORT AND THE WINGED FEMALE ADAPTER OF THE TUBING SET. IT WAS REPORTED THAT THE REMOVABLE CLAVE PORT WAS TIGHTENED TO THE FEMALE ADAPTER AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92890 EXT SET 7IN REM CLAVE SITE NDEHP 80FPA FPA HOSPIRA LTD. NA 322584W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK