BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROB NEL CATHETER

    MDR report key: 140490 · Received December 30, 1997

    Report

    Report Number
    1314426-1997-00029
    Event Type
    Injury
    Date Received
    December 30, 1997
    Report Date
    December 3, 1997
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    KOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LOT HISTORY WAS UNREMARKABLE. NO OTHER COMPLAINTS HAVE BEEN RECEIVED AGAINST THIS LOT. DUE TO THE NATURE OF THERMOSENSITIVE POLYVINYL MATERIAL, THERE ARE SOME VARIATIONS IN STIFFNESS FROM BATCH TO BATCH. CO ADVISED THE CUSTOMER THAT CHILLING OR COOLING THE CATHETER PRIOR TO USE WILL STIFFEN THE CATHETER. THIS TECHNIQUE MAY HELP THE CUSTOMER USE THE PRODUCT WITH MORE COMFORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS, THE CATHETERS SUPPLIED TO HIM ARE SOFTER THAN OTHERS HE HAD TRIED BEFORE. BECAUSE OF THIS, THE CATHETERS COLLAPSE IN THE MIDDLE CAUSING MUCH BLEEDING. NO SERIOUS INJURY OCCURRED. NO MEDICAL INTERVENTION WAS NECESSITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROB NEL CATHETER CATHETER KOD SHERWOOD DAVIS AND GECK NA 449655

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other