BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED IV ADMIN SET, 20DRP 1 NF PORT 75

    MDR report key: 21556092 · Received March 8, 2025

    Report

    Report Number
    9617594-2025-00434
    Event Type
    Malfunction
    Date Received
    March 8, 2025
    Date of Event
    February 2, 2025
    Report Date
    April 9, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT COULD NOT BE CONFIRMED BY INVESTIGATION. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. LOT HISTORY REVIEW COULD NOT BE REVIEWED DUE TO THE UNKNOWN LOT NUMBER. ADDITIONAL INFORMATION D9 - DEVICE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE SAMPLE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    GCM RECEIVED AN EMAIL ON 07-FEB-2025 WITH COMPLAINT NUMBER (B)(4) FROM MS. (B)(6), A MCKESSON QA OF MCKESSON MEDICAL-SURGICAL FORWARDING A COMPLAINT FROM DR. (B)(6) OF BEE WELL CLINIC PLLC WITH REGARDS TO A IV ADMIN SET, 20DRP 1 NF PORT 75" WITH UNKNOWN LIST NUMBER AND LOT NUMBER 20240628. THE REPORTER STATED THAT THE TUBING LEAKS AT THE Y-CONNECTION. THE EVENT DATE WAS UNKNOWN. STATUS WAS UNKNOWN. THE SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED. GCABANG 10-FEB-2025

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280772 UNSPECIFIED IV ADMIN SET, 20DRP 1 NF PORT 75 SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown