BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREMICATH

    MDR report key: 6155663 · Received December 8, 2016

    Report

    Report Number
    2245270-2016-00084
    Event Type
    Death
    Date Received
    December 8, 2016
    Date of Event
    November 11, 2016
    Report Date
    December 8, 2016
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K954302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO VYGON FOR DEVICE EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITHIN THIRTY DAYS OF CONCLUSION VIA FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS NOT CONFIRMED. EXAMINATION OF THE SAMPLE RETURNED SHOWED THAT THE CATHETER WAS COMPLETE. ITS BLACK TIP WAS VISIBLE, BUT IT WAS INITIALLY BLOCKED. MICROSCOPIC EXAMINATION SHOWED THAT THE CATHETER TIP WAS CLOTTED AT A FEW MILLIMETERS. THEREFORE THE CATHETER WAS PLACED INTO A MARANON H CLEANING SOLUTION. AFTERWARDS, THE CATHETER SHOWED FREE FLOW WITHOUT ANY LEAK. THE CATHETER RETURNED COMPLIED TO ITS SPECIFICATION. UNFORTUNATELY NO FURTHER INFORMATION REGARDING THE CIRCUMSTANCES OF THIS INCIDENT IS AVAILABLE. AS THERE IS NO LINK BETWEEN THE BABY'S DEATH AND THE CATHETER, NO VIGILANCE REPORT IS NECESSARY.

    Description of Event or Problem · 1

    AFTER BABY'S DEATH THE CUSTOMER ASKED US TO EXAMINE THE CATHETER. FOR THE MOMENT, NO FURTHER INFORMATION AVAILABLE. OUTCOME: DEATH, BUT FOR THE MOMENT NO CONNECTION TO CATHETER SEEN BY USER.

    Description of Event or Problem · 1

    AFTER BABY'S DEATH THE CUSTOMER ASKED US TO EXAMINE THE CATHETER. FOR THE MOMENT, NO FURTHER INFORMATION AVAILABLE. OUTCOME: DEATH, BUT FOR THE MOMENT NO CONNECTION TO CATHETER SEEN BY USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805787 PREMICATH LONG TERM INTRAVASCULAR CATHETER LJS VYGON GMBH 1261.20 060616GI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death