BEUDAMED
    FDA Adverse Event Death Summary report: N

    L-CATH PICC

    MDR report key: 1938530 · Received December 20, 2010

    Report

    Report Number
    1625425-2010-00032
    Event Type
    Death
    Date Received
    December 20, 2010
    Date of Event
    September 6, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED IN A SUPPLEMENTAL REPORT WHEN RECEIVED.

    Description of Event or Problem · 1

    THIS INCIDENT OCCURRED ON (B)(6) 2010, AND CONCERNED A PREMATURE BABY. BATCH NUMBER AND SAMPLE ARE NOT AVAILABLE. SAMPLE WAS NOT ANALYZED ONCE REMOVED FROM THE PT, SO NO ADDITIONAL INFO FOR THE INVESTIGATIONS. INFORMED THAT THIS INCIDENT WAS NOT DECLARED AS REPORTABLE IN (B)(4), BECAUSE THE USERS HAVE CONSIDERED THAT THE CAUSE OF THE PROBLEM WAS LINKED TO THE ACT (THIS KIND OF COMPLICATION IS WELL KNOWN AND ESPECIALLY WITH SO LITTLE BABY) AND NOT TO A PRODUCT DEFECT. THE REASON WHY THEY HAVE DECLARED THIS INCIDENT REPORTABLE ON (B)(4), IS THAT THEY HAD A SIMILAR INCIDENT (PERFUSO-THORAX) THREE DAYS BEFORE, BUT WITHOUT CRITICAL CONSEQUENCES FOR THE BABY (WHO IS SAFE). THE DEVICE DIDN'T APPEAR DEFECTIVE, BUT AS IT WAS THE SECOND CASE IN A SHORT TIME FRAME, THEY DECLARED THE TWO INCIDENTS TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH PICC L-CATH LJS ARGON MEDICAL DEVICES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death