BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SECONDARY ADMINISTRATION SET

    MDR report key: 3170899 · Received June 5, 2013

    Report

    Report Number
    9616066-2013-00412
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER INDICATED THE SET WOULD BE RETURNED, HOWEVER IT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WITH EVALUATION RESULTS WILL BE SUBMITTED SHOULD THE AFFECTED PRODUCT BE RECEIVED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SECONDARY TUBING CRACKED AT THE HUB AND LEAKED. THERE WAS NO PATIENT HARM REPORTED. MEDICAL INTERVENTION WAS NOT REQUIRED. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249599 ALARIS SECONDARY ADMINISTRATION SET FPA CAREFUSION CORPORATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PRIMARY ADMINISTRATION SET:| MANUFACTURER UNCONFIRMED, MODEL/LOT UNK