BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC CATH PACK

    MDR report key: 24545979 · Received March 9, 2026

    Report

    Report Number
    1047429-2026-00002
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 18, 2026
    Report Date
    April 22, 2026
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    OEZ
    UDI-DI
    10809160512159
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT IS SAID TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED YET. AVID MEDICAL IS A CONVENIENCE KIT MANUFACTURER. THE COMPLAINT COMPONENT IS SOUTHMEDIC (REGISTRATION NUMBER: 8022032) PART NUMBER 5316285, LOT NUMBER W1007576. A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO THE COMPONENT MANUFACTURER ON MARCH 6, 2026. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO NONCONFORMANCES WERE IDENTIFIED FOR THE AFFECTED COMPONENT. CLEANING RECORDS FROM THE TIME OF MANUFACTURE WERE ALSO REVIEWED, WITH NO ISSUES NOTED. A VISUAL INSPECTION OF CURRENT WAREHOUSE INVENTORY FOR THE COMPONENT FOUND NO DEFECTS. ALL REQUIRED QUALITY INSPECTIONS WERE COMPLETED IN ACCORDANCE WITH ESTABLISHED PROCEDURES, WITH NO DISCREPANCIES OBSERVED. A 12-MONTH REVIEW OF COMPLAINT DATA REVEALED NO PRIOR COMPLAINTS OR TRENDS ASSOCIATED WITH THIS ISSUE, INDICATING THIS IS THE FIRST REPORTED OCCURRENCE. THE SITUATION WILL CONTINUE TO BE MONITORED. ADDITIONALLY, WAREHOUSE STORAGE LOCATIONS FOR THE COMPONENTS WERE ASSESSED, AND THE PLACEMENT OF THE SCALPEL WAS REVISED TO THE CENTER OF THE TRAY. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT-(B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE BLADE PROTECTOR WAS NOT FUNCTIONING PROPERLY, LEAVING THE BLADE EXPOSED. AS A RESULT, ONE TECHNICIAN SUSTAINED A CUT DUE TO THE ISSUE. NO MEDICAL INTERVENTION WAS REQUIRED, THIS OCCURRED PRIOR TO USE WITH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60703 CARDIAC CATH PACK CARDIAC CATH PACK OEZ AVID MEDICAL, INC. JACK449 1664798 10809160512159

    Patients

    Seq Age Sex Outcome Treatment
    1