BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LFSHLD MALE ADPTR

    MDR report key: 2971105 · Received February 1, 2013

    Report

    Report Number
    9615050-2013-00157
    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 DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS 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

    THE CUSTOMER CONTACT REPORTED DIFFICULT TO CONNECT; SUBSEQUENTLY, BLOOD LOSS WAS NOTED. THE MALE ADAPTER PLUG WAS TO BE CONNECTED TO THE FEMALE ADAPTER OF AN UNSPECIFIED IV CATHETER. IT WAS REPORTED THAT THE MALE ADAPTER PLUG WAS DIFFICULT TO CONNECT TO THE FEMALE ADAPTER OF THE IV CATHETER AND AN UNSPECIFIED VOLUME OF BLOOD LEAKED FROM THE IV CATHETER. THE MALE ADAPTER PLUG WAS REPLACED AND THE THERAPY WAS INITIATED. 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 ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45293 LFSHLD MALE ADPTR 80FPK FPK HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

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