BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JET PORT PLUS CATHETER SYSTEM

    MDR report key: 2627475 · Received November 7, 2007

    Report

    Report Number
    2032582-2007-00004
    Event Type
    Malfunction
    Date Received
    November 7, 2007
    Date of Event
    September 21, 2007
    Report Date
    November 7, 2007
    Manufacturer
    PFM MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K000125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2007: RECEIVED REPORT THAT 'PORT WITH HUB BROKE OFF'. TRIED TO CONTACT COMPLAINANT - LEFT MESSAGE. ON (B)(4) 2007: (B)(6) FROM (B)(6) MEDICAL CENTER RESPONDS. REPORTS THE CATHETER BROKE OFF AT THE HUB AND WENT INTO THE PT'S HEART. ACCORDING TO THE NURSE, THIS DID NOT CAUSE THE PT A SERIOUS PROBLEM. IMPLANT DATE: (B)(6) 2006. EXPLANT DATE: (B)(6) 2007. ATTENDING PHYSICIAN DR. (B)(6). COMPLAINANT TO SEND ONLY PORT BACK TO PFM MEDICAL. CATHETER IS NOT AVAILABLE. CLIENT HAS NOT RESPONDED TO MULTIPLE REQUESTS REGARDING RETURN OF SAMPLE. WITHOUT SAMPLE, UNABLE TO PROPERLY INVESTIGATE COMPLAINT. REVIEW OF PAST COMPLAINTS AND LABELING INDICATE THE FOLLOWING: HISTORICALLY, CATHETER BROKE OFF AT HUB INDICATES THAT THE CATHETER HAD DISCONNECTED FROM THE PORT. THE IFU CLEARLY STATES HOW TO CONNECT THE CATHETER TO PORT AND TO ASSURE PROPER CONNECTION. HISTORICALLY, CATHETER BROKE INDICATES THAT THE CATHETER WAS PLACED BETWEEN THE CLAVICLE AND THE FIRST RIB CREATING A 'PINCH OFF'. THIS CONDITION IS CLEARLY IDENTIFIED IN THE IFU. SINCE THE DEVICE HAD BEEN IMPLANTED FOR OVER 9 MONTHS HAVE TO CONCLUDE THAT A PINCH OFF CONDITION EXISTED. UNABLE TO DETERMINE CAUSE FOR FAILURE. HISTORICALLY SIMILAR EVENTS INDICATE THAT THE DEVICE WAS IMPROPERLY PLACED AS INDICATED IN THE IFU. (B)(4); PFM MEDICAL, INC.

    Description of Event or Problem · 1

    THE CATHETER BROKE OFF AT THE HUB AND WENT INTO THE PT'S HEART. ACCORDING TO THE NURSE THIS DID NOT CAUSE THE PT A SERIOUS PROBLEM. IMPLANT DATE: (B)(6) 2006. EXPLANT DATE: (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JET PORT PLUS CATHETER SYSTEM IMPLANTED PORT AND CATHETER LJT PFM MEDICAL 616.468.1080-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention