BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET 7IN REM CLAVE SITE NDEHP

    MDR report key: 3850898 · Received February 12, 2014

    Report

    Report Number
    9613251-2014-00029
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 9, 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 DEVICES WERE 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

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF LEAKS. ON UNSPECIFIED DATES, SECURE LOCK MALE ADAPTER OF THE EXTENSION TUBING SETS WERE BING USED TO DELIVER UNSPECIFIED MEDICATIONS VIA POWER INJECTORS. AT AN UNSPECIFIED TIME, THE CUSTOMER CONTACT REPORTED THAT UNSPECIFIED VOLUMES OF SOLUTION LEAKED FROM THE CONNECTION BETWEEN THE REMOVABLE CLAVE PORTS AND THE WINGED FEMALE ADAPTERS OF THE TUBING SETS. IT WAS REPORTED THAT THE REMOVABLE CLAVE PORTS WERE TIGHTENED TO THE FEMALE ADAPTER AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92891 EXT SET 7IN REM CLAVE SITE NDEHP 80FPA FPA HOSPIRA LTD. NA 322584W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK