BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONV PIN IV FAT CLVE

    MDR report key: 3030912 · Received March 28, 2013

    Report

    Report Number
    9615050-2013-00558
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K982159
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED A POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBER IS 240095H. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A CRACK IN THE SEMI-RIGID ADAPTER OF THE SECONDARY PORT. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT A CRACK IN THE SEMI-RIGID ADAPTOR OF THE SECONDARY POST WAS NOTED. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. ALTHOUGH THERE WAS POTENTIAL FOR A LEAK, NO LEAKAGE WAS REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF TUBING SET WAS REPLACED AND THE THERAPY RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129690 CONV PIN IV FAT CLVE 80FRN FRN HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK