BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM SOL 2INTG CLAVE

    MDR report key: 3970722 · Received April 29, 2014

    Report

    Report Number
    9615050-2014-03084
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Report Date
    April 2, 2014
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED AND EVALUATED. TESTING FOUND THE DEVICE LEAKED AT THE DISTAL END OF THE SOLUSET BETWEEN THE LOWER LID OF THE SOLUSET AND THE PRINTED CYLINDER. THIS WAS DUE TO INSUFFICIENT SOLVENT APPLICATION. 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. IT WAS REPORTED THAT THE PIERCING PIN OF THE TUBING SET WAS INSERTED INTO THE ADMINISTRATION PORT OF THE SOLUSET AND THE SOLUSET WAS FILLED WITH SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE NURSE PUMPED THE CUSTOMER REPORTED BULB BELOW THE BURETTE OF THE TUBING SET. NO SPECIFIC DETAILS WERE PROVIDED. AT THIS TIME, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM A CRACK AT AN UNSPECIFIED LOCATION OF THE SOLUSET. NO SPECIFIC DETAILS WERE PROVIDED. NO INFO WAS PROVIDED IF THE LEAK OCCURRED DURING OR PRIOR TO PT USE; HOWEVER, THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY. NO MED INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255609 PLM SOL 2INTG CLAVE 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK