BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOMAGIC

    MDR report key: 13860670 · Received March 23, 2022

    Report

    Report Number
    13860670
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 7, 2022
    Manufacturer
    NEO MEDICAL INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: QUALITY AND SAFETY CONCERNS RELATED TO THE NEOMAGIC EXTENDED DWELL CATHETER (EDC) 1.9 FR. X 8CM WITH STYLE. COULDN¿T ADVANCE THE NEOMAGIC EDC CATHETERS BEYOND THE 7 CENTIMETER MARK DUE TO ROUGHNESS AND IRREGULARITY ON THE CATHETER. THERE WAS AN ADDITIONAL INCIDENT WITH CATHETER LEAKAGE AT THE 8 CM MARK. HEALTH CARE PROVIDER PULLED LOT #1028 CATHETERS AND RE-INSPECTED THEM AND FOUND THAT APPROXIMATELY ½ HAD THIS SAME ROUGHNESS AT THE 7-8 CENTIMETER MARK. COMMUNICATION WAS SENT TO NEO MEDICAL INC. NEOMEDICAL RESPONSE: SALES/CLINICAL REPRESENTATIVE WAS ABLE TO TALK TO THE QUALITY ASSURANCE TEAM EARLIER THIS AFTERNOON ABOUT THE EPIVS AND THE POSSIBILITY OF WHAT MIGHT BE HAPPENING. COMPANY REPRESENTATIVE SENT A PHOTO OF THE DEFLASHING PROCESS OF OUR EPIV CATHETERS. THIS IS PART OF THE MOLDING PROCESS. IS THE ROUGHNESS YOU ARE REFERRING TO DEPICTED ON THE 'AFTER DEFLASHING' PICTURE? IF SO, THIS IS NORMAL TO OUR CATHETER ASSEMBLIES. OUR QA TEAM WOULD JUST LIKE TO KNOW IF THIS IS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864720 NEOMAGIC CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ NEO MEDICAL INC. 1943-1608 1028

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown