BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDARY SET 34IN NDEHP

    MDR report key: 3902059 · Received May 2, 2014

    Report

    Report Number
    9615050-2014-03180
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 9, 2014
    Manufacturer
    HOSPIRA COSTA RICA 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 DEVICE WAS RECEIVED. 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 A LEAK. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF CLINDAMYCIN. IT WAS REPORTED THAT DURING PRIMING PRIOR TO PT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE AIR FILTER VENT ON THE PIERCING PIN OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED; HOWEVER THE CUSTOMER CONTACT THOUGHT THE LEAK MAY HAVE OCCURRED DURING BACKPRIMING OF THE TUBING SET. THERE WERE NO REPORTS OF ANY ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266078 SECONDARY SET 34IN NDEHP 80FPA FPA HOSPIRA COSTA RICA LTD. NA 340744W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA