BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFM TITA JET LIGHT II

    MDR report key: 2841323 · Received September 23, 2012

    Report

    Report Number
    2032582-2012-00009
    Event Type
    Malfunction
    Date Received
    September 23, 2012
    Date of Event
    August 21, 2012
    Report Date
    September 21, 2012
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJS
    PMA / PMN Number
    K072481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REVIEWS WERE CONDUCTED AND THE FOLLOWING RESULTS WERE FOUND: A DHR REVIEW SHOWED NO NON-CONFORMITY. A SIMILAR COMPLAINT WAS REPORTED FOR PT (B)(6); REFERENCE (B)(4). THE TENSILE TEST (MEASUREMENT OF THE NECESSARY FORCE TO DISCONNECT THE CATHETER) PROVIDED BY THIS LOT# WAS 18.95N (ACCEPTABLE CRITERIA IS >5N). SINCE THE CUSTOMER REFUSED TO PROVIDE THE TWO (2) SUSPECTED/DEFECTIVE PORTS FOR INVESTIGATION, WE WERE ONLY ABLE TO TEST THE PORTS THAT THEY SENT FROM THE SAME LOT #. ON (B)(4) 2012; THREE (3) UNITS FROM THE SAME LOT# (120307000) WERE TESTED AND THE AVERAGE TENSILE STRENGTH WAS MEASURED AT 17.4N (SPECIFICATION > 5N). THEREFORE, TESTING OF THE FORCE OF THE CATHETER DISCONNECTION ON THESE THREE PORTS CONFORMED TO SPECIFICATIONS. BASED ON NOT HAVING THE ACTUAL FAILED PORTS FOR INVESTIGATION AND TESTING OF THREE (3) PORTS FROM THE SAME LOT# CONVEYED THAT ALL PORTS CONFORMED TO SPECIFICATIONS, PFM WAS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE TWO (2) FAILED PORTS IN QUESTION. REDUCTION MEASURES ARE IN PLACE TO MITIGATE THIS RISK, WHICH IS KNOWN AND IDENTIFIED IN OUR RISK ANALYSIS REPORT. PFM WILL CONTINUE TO MONITOR FOR THESE TYPES OF SIMILAR COMPLAINTS IN THE FUTURE.

    Description of Event or Problem · 1

    INITIAL REPORT RECEIVED BY PFM ON (B)(6) 2012 NOTED THAT "THE RESERVOIR AND LOCKING MECHANISM ARE REMAINING IN PLACE, BUT THAT THE CATHETER IS BREAKING LOOSE AND ENDED UP IN THE RIGHT HEART DURING INJECTION." ON (B)(6) 2012: ADDITIONAL INFO RECEIVED BY PFM INCLUDED 2 MEDWATCH REPORTS; ONE OF PT (B)(6) AND ONE FOR PT (B)(6) (REF MDR#2032582-2012-00009). THE CUSTOMER NOTED THAT "DURING RETRIEVAL OF THE CATHETERS AND REMOVAL OF THE RESERVOIR, THE LOCKING SYS IS INTACT AND THE CATHETER IS WHOLE. THE CATHETER IS COMPLETELY BEING INJECTED OFF THE HUB AND OUT FROM THE LOCKING MECHANISM. WE HAVE HAD 2 ENCOUNTERS AND HAVE NOT EVER HAD THIS ISSUE OUT OF APPROX 1800 PLACEMENTS. THE ONLY COMMON DENOMINATOR IS THE LOT NUMBER. WE CURRENTLY HAVE 3 ON HAND AND WILL SEND BACK TO YOU TOMORROW. THE RISK MGMT GROUP TOOK THE PORT AND PIECES FROM US. I STILL NEED AN RGA ISSUED FOR THE 3 PORTS BEING SENT BACK, THE 2 DAMAGED PORTS, AND THE 18 PORTS ON THE SHELF. THAT IS A TOTAL OF 23 PORTS I WOULD LIKE REPLACED. THE FINAL NUMBER MAY END UP BEING HIGHER DEPENDING ON HOW MANY THE CUSTOMER END UP SENDING BACK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFM TITA JET LIGHT II IMPLANTED PORT AND CATHETER LJS PFM MEDICAL, INC 120307000

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention