BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECNDRY SET 34IN NDEHP W/EXT HOOK

    MDR report key: 3874276 · Received April 18, 2014

    Report

    Report Number
    9613251-2014-00086
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 19, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER CONTACT IDENTIFIED TWO POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBERS ARE 310294W AND 31028W. THE INTERNATIONAL AFFILIATE WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED. NO RESPONSE HAS BEEN RECEIVED. 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 UNRESTRICTED FLOW. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. THE CUSTOMER CONTACT REPORTED THAT AFTER PRIMING PRIOR TO PATIENT USE, THE CUSTOMER HANGS THE PRIMED TUBING SET AND SOLUTION. THE CUSTOMER CONTACT REPORTED UNRESTRICTED FLOW. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. THE CUSTOMER CONTACT REPORTED IT HAS BEEN THE PROCEDURE TO PRIME THE TUBING SET WITH THE UNSPECIFIED CHEMOTHERAPEUTIC AGENT AND HANG THE PRIMED TUBING SET AND SOLUTION CONTAINER FOR A WEEK OR LESS PRIOR TO PATIENT USE. IT WAS REPORTED THAT AFTER AN UNSPECIFIED LENGTH OF TIME AFTER HANGING THE PRIMED TUBING SET, UNRESTRICTED FLOW WAS NOTED. THE CUSTOMER CONTACT REPORTED THAT SOLUTION LEAKED AROUND THE CLAMP. THE CUSTOMER CONTACT INDICATED THAT THEY SLIDE IT SHUT, BUT IT DOESN'T SEEM TO SEAL COMPLETELY. NO SPECIFIC DETAILS WERE PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238433 SECNDRY SET 34IN NDEHP W/EXT HOOK 80FPA FPA HOSPIRA LTD. NA PLOTS4W

    Patients

    Seq Age Sex Outcome Treatment
    1 NA