BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DC PLUM W/SEC CONVPN(48/CASE)

    MDR report key: 3832807 · Received March 17, 2014

    Report

    Report Number
    9615050-2014-02002
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    July 5, 2013
    Report Date
    July 8, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K865060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED ON (B)(6) 2013 AND EVALUATED. TESTING FOUND THAT SOLUTION LEAKED BETWEEN THE AIR FILTER CAP AND THE MALE ADAPTER OF THE TUBING SET. THE PROBABLE CAUSE OF LEAK FROM THE AIR FILTER COULD HAVE BEEN DUE TO THE COMPRESSION RINGS OF THE AIR FILTER ASSEMBLY, THE MOLDED OPTION-LOK MALE ADAPTER, OR INCORRECT ASSEMBLY OF THE AIR FILTER ASSEMBLY ONTO THE OPTION-LOK MALE ADAPTER DURING MANUFACTURING. 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. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET PRIOR TO PATIENT USE, AN UNSPECIFIED END OF THE TUBING SET. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156821 DC PLUM W/SEC CONVPN(48/CASE) 80FRN FRN HOSPIRA COSTA RICA LTD. NA 201395H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA