BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LSLF EXT SET W CLV

    MDR report key: 2844369 · Received November 5, 2012

    Report

    Report Number
    9613251-2012-00218
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 10, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K052722
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. 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 SEPARATION. THE EXTENSION TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. ON AN UNSPECIFIED DATE, THE CUSTOMER CONTACT INDICATED THAT A NURSE REPORTED, "THIS FELL APART AND I FOUND IT WHEN I WENT INTO THE PATIENT'S ROOM." IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE CLAVE PORT OF THE EXTENSION TUBING SET. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND IF THE THERAPY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LSLF EXT SET W CLV 80 FPA HOSPIRA LTD. NA 15211NS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK