BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH

    MDR report key: 5235667 · Received February 10, 2004

    Report

    Report Number
    2925153-2003-00019
    Event Type
    Other
    Date Received
    February 10, 2004
    Date of Event
    August 1, 2003
    Report Date
    February 1, 2004
    Manufacturer
    HDC CORP.
    Product Code
    DQY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL EXPIRATION DATES AND LOT #: 1047 - 07/01/2007, 1056 - 04/01/2008. ADDITIONAL MANUFACTURE DATE: 07/2002 OR 04/2003. A REVIEW OF THE FILES, INDICATE THAT DESPITE THE ABSENCE OF ADEQUATE EVIDENCE, THIS EVENT SHOULD BE REPORTED.

    Description of Event or Problem · 1

    BASED ON THE REPORT "IN (B)(6), PLACED A LINE ON A PREM BABY AND SECURED THE HUB WITH THE "SPSITE". SHE DISCOVERED THE LINE HAD DISINTEGRATED UNDER THE "SPSITE" AT THE HUB, AND PULLED THE LINE OUT. THE NEXT DAY ON THE SAME BABY SHE PLACED A SECOND LINE, AFTER PLACING THE LINE SHE STARTED REMOVING THE GUIDEWIRE ONLY TO FIND THAT THE WIRE WAS STRANGELY BENT AND IT CUT THE LINE TO PIECES INSIDE THE VEIN." NO OTHER INFO WAS PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH V-CATH 2 FR. 355-75 DQY HDC CORP. 355-75 1041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other