BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG SELF-CATH CH14

    MDR report key: 1642040 · Received March 28, 2010

    Report

    Report Number
    2183558-2010-00009
    Event Type
    Injury
    Date Received
    March 28, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 16, 2010
    Manufacturer
    COLOPLAST A/S
    Product Code
    EYB
    PMA / PMN Number
    K003784
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION REVEALED THE TIP OF THE CATHETER HAD AN OPENED END WITH A STRAIGHT EDGE; THEREFORE, THE COMPLAINT IS CONFIRMED AS REPORTED. EXAMINATION OF THE CATHETER REVEALED NO VOIDS IN THE SEAL OF THE POUCH WHICH WOULD HAVE INDICATED A CUT-OFF CATHETER. FURTHER EXAMINATION REVEALED THE CATHETER HAD MISSED THE TIP- FORMING PROCESS, WHICH LEFT THE TIP UNFORMED AND OPEN WITH A STRAIGHT EDGE. THE COMPLAINT HISTORY WAS REVIEWED, REVEALING THAT THIS IS THE FIRST SUCH COMPLAINT FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    (B) (6). ACCORDING TO THE INFORMATION RECEIVED, AN END-USER REPORTED A CATHETER WITH A CUT-OFF / BLUNT TIP. THE PATIENT WROTE A LETTER INDICATING HE COULD NOT FIGURE OUT WHY IT WAS SO DIFFICULT TO INSERT THE CATHETER & THEN HE NOTICED BLOOD IN HIS URINE. UPON FURTHER INSPECTION, HE FOUND THE TIP WAS NON-EXISTENT AND THE END WAS BLUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG SELF-CATH CH14 INTERMITTENT CATHETER EYB COLOPLAST A/S 5022101400 2119238

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention