BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDARY IV SET-SL/CE (50/CS)

    MDR report key: 3061576 · Received April 11, 2013

    Report

    Report Number
    9615050-2013-00684
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 13, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPK AND HAS A 510K OF K063239. 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 SPLIT IN THE TUBING; SUBSEQUENTLY A LEAK WAS NOTED. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET PRIOR TO PATIENT USE, A SPLIT IN THE TUBING WAS NOTED AT AN UNSPECIFIED LOCATION ON THE TUBING SET. IT WAS REPORTED UNSPECIFIED VOLUME OF SOLUTION LEAKED. 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
    155547 SECONDARY IV SET-SL/CE (50/CS) UNK FRN HOSPIRA COSTA RICA LTD. NA 251645G

    Patients

    Seq Age Sex Outcome Treatment
    1 NA