BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM SET W/2 CLV PE LINED LIGHT PROTEC

    MDR report key: 3424446 · Received October 15, 2013

    Report

    Report Number
    9615050-2013-03971
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Date of Event
    August 1, 2013
    Report Date
    September 16, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT. THE COMMODITY ON THE INTERNATIONAL LIST NUMBER THAT MALFUNCTIONED IS COMPARABLE TO THE COMMODITY ON THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FRN AND HAS A 510K OF K982159. 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 CONCENTRATION OF SALINE. THE CUSTOMER CONTACT REPORTED THAT DURING PRIMING PRIOR TO PT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED BETWEEN THE CONNECTION OF THE TUBING AND THE SECURE LOCK MALE ADAPTER OF THE TUBING SET. THOUGH REQUEST, 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
    529283 PLUM SET W/2 CLV PE LINED LIGHT PROTEC UNK FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 NA