BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RED RUBBER ROBINSON CATHETER

    MDR report key: 120711 · Received September 18, 1997

    Report

    Report Number
    9610849-1997-00017
    Event Type
    Injury
    Date Received
    September 18, 1997
    Report Date
    August 19, 1997
    Manufacturer
    KELSAR, S.A.
    Product Code
    FCN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    NINETY SAMPLES WERE RETURNED FOR EVALUATION. THERE WAS NO VISIBLE DEFECT OF DAMAGE. DIAMETER OF CATHETER WAS MEASURED AND WAS WITHIN SPECIFICATION. LOT HISTORY WAS REVIEWED AND WAS UNREMARKABLE WITH REGARD TO THE COMPLAINT. NO OTHER COMPLAINTS HAVE BEEN RECEIVED AGAINST THIS LOT. NATURAL VARIATIONS IN CATHETER MATERIAL AND/OR DIMENSIONS MAY ACCOUNT FOR THE CUSTOMER'S PERCEIVED DIFFERENCE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS HE HAD INJURED HIMSELF TWICE BY PUNCTURING MEMBRANE AND CAUSING BLEEDING. HE FEELS THE ID OF THE CATHETER IS CONSIDERABLY SMALLER AND THE CATHETER IS MUCH STIFFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RED RUBBER ROBINSON CATHETER DRAINAGE CATHETER FCN KELSAR, S.A. NA 805259

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other