BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH NEW SRC IR PACK

    MDR report key: 22478146 · Received July 11, 2025

    Report

    Report Number
    22478146
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    April 9, 2025
    Report Date
    June 20, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    OIO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGICAL TECH- AND RN WERE OPENING STERILE SUPPLIES FOR AN ANGIOGRAM PROCEDURE. WHEN OPENING THE ""NEW SRC IR PACK"" AND COUNTING LARGE LAPS WE SAW THAT THERE WERE ONLY FOUR LAPS PRESENT WHEN THERE SHOULD BE FIVE. INFORMATION FROM THE PACK IS LISTED BELOW: CATALOG: SANOCIPSRC LOT# 444758 MFG DATE: 2025-01-14 EXP DATE: 2027-11-01 THE INCORRECT LAP COUNT WAS TAKEN OUT OF THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872614 CARDINAL HEALTH NEW SRC IR PACK RADIOGRAPHIC CONTRAST TRAY OIO CARDINAL HEALTH 200, LLC SANOCIPSRC 444758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown