BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP 3CLV YSTE MACR

    MDR report key: 4844500 · Received May 1, 2015

    Report

    Report Number
    9613251-2015-00048
    Event Type
    Malfunction
    Date Received
    May 1, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 17, 2015
    Manufacturer
    HOSPIRA LTD REG NO: 9613251
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. 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 AT THE VERY DISTAL END WHERE THE FLEXIBLE TUBING GOES INTO THE HARD PLASTIC TUBING. IT WAS REPORTED THE TUBING SET WAS USED TO DELIVER LACTATED RINGERS SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME, A LEAK WAS NOTED AT THE VERY DISTAL END WHERE THE FLEXIBLE TUBING GOES INTO THE HARD PLASTIC TUBING. AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. THE CUSTOMER CONTACT REPORTED NO PHYSICAL DEFECTS COULD BE SEEN IN THE TUBING SET. THERE WERE NO REPORTED ADVERSE PATIENT EVENTS AND NO REPORTED DELAY OF THERAPY CRITICAL FOR THE PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289550 NDEHP 3CLV YSTE MACR 80FPA FPA HOSPIRA LTD REG NO: 9613251 NA 460404W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK