BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD ADMINISTRATION SETS WITH FLOW STOP

    MDR report key: 16017021 · Received December 20, 2022

    Report

    Report Number
    3012307300-2022-28002
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    October 15, 2022
    Report Date
    April 28, 2023
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586029646
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H10: DEVICE EVALUATION: THE SAMPLE WAS RETURNED FOR INVESTIGATION. SAMPLE WAS RECEIVED IN USED CONDITIONS WITHOUT ORIGINAL PACKAGING, DECONTAMINATED AND INSIDE A PLASTIC BAG. VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION SHOWED THAT NO DAMAGES, OBSTRUCTION OR ANY OTHER DEFECTS IN THE JOINTS OF THE PRODUCT. FOR FUNCTIONAL TESTING, THE SAMPLES WERE SET FOR ACCURACY TESTING; SAMPLE ONE PASSED; SAMPLE TWO FAILED; SAMPLE THREE FAILED; SAMPLE FOUR PASSED. THE FAILURE MODE REPORTED WAS CONFIRMED. THE ROOT CAUSE WAS TRACED TO THE SUPPLIER AND MANUFACTURING. CAPA-000903 WAS OPENED ON (B)(6) 2022 TO INVESTIGATE THE UNDER-DELIVERY/ NON-DELIVERY ISSUE REPORTED, AND TO SERVE ALSO FOR CORRECTIVE ACTION. A DHR (DEVICE HISTORY REVIEW) WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW. 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 THE DEVICE UNDER DELIVERED THE MEDICATION. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2700668 CADD ADMINISTRATION SETS WITH FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7322-24 10610586029646

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male