BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIR

    MDR report key: 9521120 · Received December 26, 2019

    Report

    Report Number
    3012307300-2019-06994
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    November 27, 2019
    Report Date
    March 5, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586032370
    PMA / PMN Number
    K081156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE RESERVOIR CASSETTE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE FOUND IT TO BE IN GOOD PHYSICAL CONDITION. DEVICE UNDERWENT FUNCTIONAL TESTING BY USING A SYRINGE TO DETECT FOR LEAKING IN THE CASSETTE. DURING THE TEST A LEAK WAS OBSERVED, CONFIRMING THE REPORTED CUSTOMER ALLEGATION. THE PROBLEM SOURCE HAS BEEN DETERMINED TO BE EITHER THE BAG WAS DAMAGED DURING THE ASSEMBLY PROCESS DUE TO A WORN TOOL, OR THE BAG WAS MISHANDLED DURING THE LEAK TEST DURING MANUFACTURING.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT MEDICATION LEAKED OUT OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR WHEN 200CC OF ANTICANCER AGENT WAS BEING FILLED WITH A SYRINGE (4TH OF 4 SYRINGES). THERE WAS NO PATIENT INJURY. POSSIBLE LOT NUMBERS ARE 3863367 AND 3852998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315869 CADD CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7308-24 10610586032370

    Patients

    Seq Age Sex Outcome Treatment
    1