BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LFSHLD MALE ADPTR

    MDR report key: 2971128 · Received February 1, 2013

    Report

    Report Number
    9615050-2013-00159
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 2, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K941214
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICES WERE DISCARDED. THE LOT NUMBER OF THE DEVICES THAT WERE IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED FOUR POSSIBLE LOT NUMBERS (PLOTS). THE POSSIBLE LOT NUMBERS ARE 110535H, 950625H, 100925H, AND 090615H. INVESTIGATION IS NOT COMPLETE. 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 DIFFICULT TO CONNECT; SUBSEQUENTLY, BLOOD LOSS WAS NOTED. THE MALE ADAPTER PLUGS WERE TO BE CONNECTED TO THE FEMALE ADAPTER OF UNSPECIFIED IV CATHETERS. IT WAS REPORTED THAT THE MALE ADAPTER PLUGS WERE DIFFICULT TO CONNECT TO THE FEMALE ADAPTER OF THE IV CATHETERS AND UNSPECIFIED VOLUMES OF BLOOD LEAKED FROM THE IV CATHETERS. THE MALE ADAPTER PLUGS WERE REPLACED AND THE THERAPIES WERE INITIATED. 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 INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45399 LFSHLD MALE ADPTR 80FPK FPK HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED IV CATHETERS, MFR UNK