BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIRS - NON FLOW STOP

    MDR report key: 15410143 · Received September 13, 2022

    Report

    Report Number
    3012307300-2022-18890
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    July 31, 2020
    Report Date
    September 13, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. DEVICE INFORMATION AND PROTOCOL # ARE UNKNOWN. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE EACH OF THE KITS WERE OPENED AND MISSING THE NEEDLE CANULA ASSEMBLY. THEY ARE NOT SURE OF THE ACTUAL LOT NUMBER BUT THEY DO HAVE ON HAND INVENTORY LOT NUMBERS 3979600 AND 3991702. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2608169 CADD CASSETTE RESERVOIRS - NON FLOW STOP PUMP, INFUSION FRN ST PAUL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown