BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODAN UNIVERSAL SECONDARY SET

    MDR report key: 3980630 · Received June 20, 2014

    Report

    Report Number
    9616066-2014-00596
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    February 19, 2014
    Report Date
    June 3, 2014
    Manufacturer
    CODAN US CORP.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. THIS PRODUCT IS DISTRIBUTED BY (B)(4) AND MANUFACTURED BY CODAN. THIS REPORT IS FILED BY THE DISTRIBUTOR: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MALE LUER TIP OF THE SECONDARY SET BROKE OFF IN THE PORT OF THE PRIMARY SET. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364327 CODAN UNIVERSAL SECONDARY SET SECONDARY SET FPA CODAN US CORP. A 492 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE PRIMARY ADMINISTRATION SET| MODEL 2426-0500/LOT: UNK