BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO

    MDR report key: 11457072 · Received March 10, 2021

    Report

    Report Number
    3012307300-2021-01873
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 8, 2021
    Report Date
    March 11, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FOZ
    UDI-DI
    15019517078435
    PMA / PMN Number
    K160235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6: PATIENT CODE.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT UPON OPENING A PACKAGE FOR A SMITHS MEDICAL JELCO SAFETY VIAVALVE CATHETER, SOME INCORRECT ITEMS WERE FOUND. WITHIN THE PACKAGE, ITEM 3067, LOT 3997707 WERE FOUND INSTEAD OF A VIAVALVE 4033919. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355136 JELCO INTRAVASCULAR CATHETER FOZ SMITHS MEDICAL ASD, INC. 326710 4033919 15019517078435

    Patients

    Seq Age Sex Outcome Treatment
    1