BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECNDRY SET 34IN NDEHP

    MDR report key: 3802047 · Received February 4, 2014

    Report

    Report Number
    9613251-2014-00017
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 14, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. A REPRESENTATIVE DEVICE FROM AN UNSPECIFIED LOT WILL BE EVALUATED. 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 LEAK. ON AN UNSPECIFIED DATE, THE MALE ADAPTER ON THE OPTION-LOK MALE ADAPTER OF THE SECONDARY TUBING SET WAS CONNECTED TO THE CLAVE SECONDARY PORT ON THE CASSETTE OF A PLUMSET FOR A PIGGYBACK DELIVERY OF CLINDAMYCIN 900 MG/500 ML IN A GLASS BOTTLE. IT WAS REPORTED THAT THE AIR VENT ON THE PIERCING PIN OF THE SECONDARY TUBING SET WAS OPENED FOR THE GLASS BOTTLE DELIVERY. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE AIR VENT FILTER ON THE PIERCING PIN OF THE SECONDARY TUBING SET AFTER THE SECONDARY TUBING SET WAS BACKPRIMED FOR AN UNSPECIFIED REASON. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTS OF ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73526 SECNDRY SET 34IN NDEHP 80FPA FPA HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK