BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER

    MDR report key: 51960 · Received November 22, 1996

    Report

    Report Number
    1314426-1996-00006
    Event Type
    Malfunction
    Date Received
    November 22, 1996
    Report Date
    October 25, 1996
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED ON 8/14/1997 WHEN SAMPLES WERE RETURNED BY THE CUSTOMER. CO REC'D: 8888-160531, 160553, 160336 LOTS #455191, 456254, 455430 AND AN EMPTY PACKAGE FROM 8888-160333 LOT 457235. SAMPLES WERE TESTED FOR LEAKAGE AND HUBS PULLING AWAY FROM THE PIGTAIL. SEPARATION FORCES WERE MEASURED. NO FAILURES WERE OBSERVED. NO HUBS SEPARATED. LOT HISTORIES WERE UNREMARKABLE WITH REGARD TO THE COMPLAINT. CO IS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAILURE.

    Description of Event or Problem · 1

    NEONATOLOGIST REPORTED THAT ONE OF THE CATHETER HUBS BROKE OFF WHILE THE CATHETER WAS IN PLACE, LEAVING ONLY ONE LUMEN AVAILABLE. HE STATED THAT HE HAD TO REPLACE THE CATHETER TO CONTINUE WORKING ON THE PT, BUT NO INJURY AND/OR SIGNIFICANT DELAY WERE OBVIOUS AT THE TIME OF OCCURRENCE. THE PT WAS NOT IN DANGER AT ANY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER UVC FOS SHERWOOD DAVIS AND GECK NA 455191 (INVENTORY)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN