BEUDAMED
    FDA Adverse Event Summary report: N

    ARGONMEDICAL PICC CATHETER

    MDR report key: 2993960 · Received February 6, 2013

    Report

    Report Number
    MW5029222
    Date Received
    February 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ARGON MEDICAL
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WE HAVE DETECTED APPARENT DEFECTS IN ARGON MEDICAL PERIPHERALLY INSERTED CATHETERS IN 4 PTS OVER THE PAST 8 WEEKS. TINY PINHOLE DEFECTS IN THE CATHETER HAVE DEVELOPED WHILE INSERTED IN PTS. THE DEFECTS HAVE CONTRIBUTED TO SEPSIS IN ONE OF THE PTS. WE HAVE CONTACTED THE MANUFACTURER WHO IS ANALYZING THE CATHETER FOR DEFECTS. DIAGNOSIS OR REASON FOR USE: PRETERM INFANTS REQUIRING PARENTERAL NUTRITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51310 ARGONMEDICAL PICC CATHETER PICC LJS ARGON MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other