BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10F X 18CM SPLIT CATH XL

    MDR report key: 11819788 · Received May 13, 2021

    Report

    Report Number
    2518902-2021-00026
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 14, 2021
    Report Date
    June 10, 2021
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    MSD
    UDI-DI
    00884908003437
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED AT THE FACILITY. A PHOTOGRAPH WAS PROVIDED SHOWING ONE LUER IN A BAG WITH ONE CAP. THE CONTRACT MANUFACTURER CONDUCTED A REVIEW OF THE MANUFACTURE RECORDS FOR THE LOT NUMBER REPORTED. THEIR INVESTIGATION SHOWED ALL COMPONENTS OF THE CATHETER WERE MANUFACTURED, INSPECTED, AND ASSEMBLED ACCORDING TO SPECIFICATION WITH NO NON-CONFORMANCES OR ABNORMALITIES. THE INFORMATION PROVIDED INDICATED THE FAILURE OCCURRED DURING A CONTRAST INJECTION STUDY. THE DEVICE REPORTED IN THIS COMPLAINT IS NOT INDICATED OR APPROVED FOR A POWER INJECTION STUDY. USE OF THE DEVICE FOR THIS PURPOSE IS CONSIDERED OFF-LABEL USE. THE INSTRUCTIONS FOR USE STATE: THE MEDCOMP® PEDIATRIC SPLIT CATH® XL IS INDICATED FOR USE IN ATTAINING LONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS. THIS CATHETER IS INTENDED FOR LONG-TERM VASCULAR ACCESS ONLY AND SHOULD NOT BE USED FOR ANY PURPOSE OTHER THAN INDICATED IN THESE INSTRUCTIONS.

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE 2.5 FLOW PERMCATH CATHETER WAS USED FOR CONTRAST INJECTION. IN THE BLUE LUER IT WAS USED WITH A 3-WAY FAUCET, SINCE THE RED ROUTE RECEIVED SALINE SOLUTION. THE RED LUER WAS CLOSED AND THE BLUE LUER WAS OPENED, THE TAP WAS TURNED ON AT THE CONNECTION. WHEN PERFORMING THE TEST WITH SERUM IN THE INJECTOR WITH FLOW 2.5, THE TAPS AND THE WHITE PART OF THE CATHETER CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715669 10F X 18CM SPLIT CATH XL SPLIT CATH XL HEMODIALYSIS CATHETER MSD MEDICAL COMPONENTS, INC. ASPC18P-XL MPHF800 00884908003437

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention