BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUSCH ROBINSON/NELATON CATHETER 14FR

    MDR report key: 2960584 · Received February 7, 2013

    Report

    Report Number
    MW5028941
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    RUSCH/TELEFLEX MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS PERFORMING INTERMITTENT CATHETERIZATION ON HIMSELF. UPON REMOVING CATHETER, THERE WAS CONCERN THAT TIP OF CATHETER BROKE OFF IN URETHRA. BLOOD APPEARED ON JAGGED TIP OF CATHETER. UPON INSPECTION, TIP OF CATHETER WAS MISSING AND CATHETER TIP PRESENTED ABNORMAL. TIP EITHER BROKE OFF DURING INSERTION OR WAS MISSING FROM ORIGINAL PRODUCT. RUSCH/TELEFLEX WAS NOTIFIED OF PROBLEM ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51577 RUSCH ROBINSON/NELATON CATHETER 14FR CATHETER, 14FR KOD RUSCH/TELEFLEX MEDICAL 238500140 427910

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention