BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMICATH

    MDR report key: 10655892 · Received October 9, 2020

    Report

    Report Number
    2245270-2020-00100
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    August 13, 2020
    Report Date
    September 28, 2020
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO FAULTY SAMPLE WAS RETURNED, THE DOCUMENTATION OF THE INCIDENT SHOWS OBVIOUS SIGNS OF BAD POSITIONING/MOVEMENT OF THE CATHETER WHICH MIGHT HAVE CAUSED PLEURAL EFFUSION. IN THE PRODUCT'S IFU STATES: "PRECAUTIONS: THE CATHETER TIP MUST NOT BE ADVANCED INTO THE HEART (RIGHT ATRIUM) ".THE LOCATION OF THE CATHETER WITHIN THE HEART MAY CAUSE CARDIAC TAMPONADE, OR CARDIAC ARRHYTHMIAS. IT IS ADVISABLE TO MAKE CHECKS OF THE CATHETER TIP POSITION AT REGULAR INTERVALS THROUGHOUT THE USAGE OF THE CATHETER". OBVIOUSLY THE USER DID NOT FOLLOW THIS ADVICE, AS THEY STATED THAT THE CATHETER WAS NOT RADIOPAQUE. THIS IS THE FIRST INCIDENT REPORT RECEIVED FOR PLEURAL EFFUSION ON CODE 1261.207 AND THE FIRST COMPLAINT FOR BATCH NO. 170220GO. HAVING REVIEWED THE BATCH HISTORY RECORDS OF BATCH NO. 170220GO, WHICH CONSISTED OF 2380 EA, WE FOUND NO DEVIATION FROM SPECIFICATION. THE BATCH WAS RELEASED. EACH CATHETER IS LEAK AND FLOW TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. VISUAL TESTS ARE CARRIED OUT FOR PRODUCT/COMPONENT PRESENCE, THE PRESENCE IN CAVITIES AND THE INTEGRITY OF THE PRODUCT SEAL. RADIOPACITY TESTS ARE DONE WITH EACH CATHETER TUBE BATCH AFTER EXTRUSION. CATHETER TUBE CODE 6G35961012, BATCH NO. 8065071 AND 8082662 WAS USED. RADIOPACITY TESTS COMPLIED WITH THE SPECIFICATION.

    Description of Event or Problem · 1

    THE CATHETER HAS BEEN DISSEMINATED. IT WAS PLACED ON (B)(6) 2020. THE CHILD HAS SUDDENLY DETERIORATED, HE HAS LIQUID IN THE PULMONARY LEVEL. A PLEURAL PUNCTURE WAS CARRIED OUT AND FOUND THE INFUSION IN HIS LUNG. THE CATHETER HAS BEEN REMOVED, APPARENTLY UNDAMAGED. IT WAS THROWN AWAY BY THE CARE TEAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121024 PREMICATH LONG-TERM INTRAVASCULAR CATHETER LJS VYGON GMBH 1261.207 170220GO

    Patients

    Seq Age Sex Outcome Treatment
    1