BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITA JET LIGHT

    MDR report key: 19029489 · Received April 2, 2024

    Report

    Report Number
    3008737795-2024-00004
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 2, 2024
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    PXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRELIMINARY INVESTIGATION: REVIEW OF DEVICE HISTORY RECORDS FOR 61.635.83.077 LOT# 153882000: BATCH RECORDS IS COMPLETE. NO DEVIATION WAS IDENTIFIED DURING MANUFACTURING. THE PRODUCT MEETS ITS SPECIFICATION PER MANUFACTURING RECORDS. REVIEW OF NC AND CAPA NO NC OR CAPA ON PRODUCT 61.635.83.077 OR LOT#153882000 RELATED TO THIS ISSUE. RETURN PRODUCT VERIFICATION THE DEFECTIVE WAS RECEIVED ON MARCH 18, 2024. ONLY THE PORT WAS PRESENT IN THE PACKAGE. THE PRELIMINARY REVIEW OF THE RETURNED DEVICE INDICATES THAT: THE SEPTUM IS DISLODGED FROM ITS HOUSING THERE IS NO TRACE OF MISS PUNCTURE ON THE PORT BODY THERE ARE 3 TRACES OF (SUSPECTED) CORING NEEDLES IN THE SEPTUM (NOT ABLE TO CONFIRM IT). THERE ARE 2 TRACES OF CUTS IN THE SEPTUM (NOT BEING ABLE TO DEFINE THEIR TRUE ORIGIN) INVESTIGATION: A) THE COMPLAINT DESCRIPTION USER IDENTIFIED A SYSTEM OCCLUSION AND A 2ML SYRINGE WAS USED TO FLUSH THE PORT. THIS DEVICE 61.635.83.077 IS CAPABLE OF SUSTAINING PRESSURE OF UP TO 300PSI (21.5BAR) WITHOUT BEING DAMAGED. THE PRODUCT IFU PROVIDED WITH THE DEVICE STATES THAT A 10ML SYRINGE MUST BE USED FOR FLUSHING. THE USE OF A 2ML SYRINGE MAY GENERATES HIGHER PRESSURE THAN THE SYSTEM IS DESIGNED FOR. CONSEQUENTLY, THERE IS A HIGH PROBABILITY THAT, DURING THE USE OF THE 2ML SYRINGE, THE EXERTED PRESSURE WAS TOO HIGH AND CAUSED THE SEPTUM TO DISLODGE. B) PORT TESTING A 10ML SYRINGE CONNECTED WITH HUBER NEEDLE HUB-HD-225, LOT# LT-23-0327 WAS FILLED WITH TAPE WATER TO PUNCTURE THE SEPTUM AND INJECT WATER INTO THE PORT. IT RESULTED THAT NO WATER CAME OUT NOR FROM THE SEPTUM NEITHER FROM THE PIN CONNECTOR. PORT IS BLOCKED AT PIN CONNECTOR LEVEL, BUT THE CAUSE OF BLOCKAGE COULD NOT BE DETERMINED. PROBABLY RINSING PROCEDURE DESCRIBED IN THE PRODUCT IFU WAS NOT FOLLOWED. C) MEASUREMENT THE SEPTUM ON PLASTIC PORT IS MAINTAINED IN PLACE WITH A THERMO-FORMED COLLAR. PER WORK INSTRUCTION INT 5570, OVERALL HEIGHT OF THE PORT SHALL BE 13.01 +/- 0.1MM TO ENSURE TO SUSTAIN THE MAX PRESSURE OF 300PSI. THE RETURNED DEVICE WAS MEASURED AT 12.96MM, WITHIN THE DEFINED TOLERANCE. CONCLUSION OF INVESTIGATION: A MISUSE OF THE PRODUCT IS DESCRIBED BY THE USER: A 2ML SYRINGE WAS USED INSTEAD OF A 10ML. THE RETURNED PORT CHAMBER IS BLOCKED AT THE PIN CONNECTOR. THE CAUSE COULD NOT BE DETERMINED (POTENTIAL MISAPPLICATION OF THE FLUSHING PROCEDURE) MEASUREMENT OF RETURNED DEVICE CONFIRM IT MEETS ITS MANUFACTURING SPECS BASED UPON THE ABOVE, THIS COMPLAINT IS CLASSIFIED AS JUSTIFIED/ USE ERROR: PROCEDURE NOT FOLLOWED. REVIEW OF RECORDED SIMILAR COMPLAINTS: (B)(4) NO SIMILAR COMPLAINT FOR SEPTUM DISLODGEMENT. 2 COMPLAINTS FOR PORT BLOCKAGE COMPLAINT RATE BASED ON MARKETING SALES: ON (B)(6) 2014 - (B)(6) 2024: ALL MARKETS: (B)(4) PORTS COMPLAINTS' RATE (B)(4) OCCURRENCES VS. (B)(4) UNITS = (B)(4) 7.2 PPM REVIEW OF RISK ANALYSIS: STED -RISK MANAGEMENT ANALYSIS_PORTS REV7: "PORT BLOCKAGE" DUE TO USER RISKS "USE OF CORING NEEDLE" OR "NO RINCE OR LOCK PERFORMED" (WRONG MAINTENANCE/ PUNCTURE PROCEDURE) CONSEQUENCE: BLOOD CLOT, THROMBOSIS, COAGULATION DEFINED POTENTIAL OCCURRENCE RATE: <50 PPM = (B)(4) FILE D - VAS001 REV 10: "PORT BLOCKAGE" DUE TO USER RISKS "USE ERROR: MISTAKE: RULE OR KNOWLEDGE BASED ERROR" CONSEQUENCE: PATIENT DOESN'T RECEIVE REQUIRED MEDICATION. DEVICE EXCHANGE DEFINED POTENTIAL OCCURRENCE RATE: 51 TO 500 PPM = (B)(4) TO (B)(4) COMPLAINTS' RATE (B)(4) OCCURRENCES VS. (B)(4) UNITS = (B)(4) 7.2 PPM IS BELOW THE THRESHOLD. RISK IS IDENTIFIED IN OUR RISKS ANALYSIS & OCCURRENCE'S RATE BELOW DEFINED ACCEPTABLE FREQUENCY OF THE RISK ANALYSIS. CONCLUSION: THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW AND RETURNED PRODUCT INVESTIGATION. PRODUCT MEETS ITS SPECIFICATIONS PER DOCUMENTARY REVIEW. REPORTED DEFECT COULD BE CONFIRMED: PORT IS BLOCKED AND SEPTUM DISLODGED, PROBABLY DUE TO A TOO HIGH PRESSURE APPLIED & INSUFFICIENT RINSING LEADING TO BLOOD CLOT. THEREFORE, COMPLAINT IS CLASSIFIED AS JUSTIFIED / MISUSE/ PROCEDURE NOT ADEQUATELY APPLIED. THE RELATED RISK IS IDENTIFIED IN OUR RISKS ANALYSIS AND OCCURRENCE'S RATE BELOW DEFINED ACCEPTABLE FREQUENCY. THEREFORE, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    COMPLICATIONS OCCURRED AFTER IMPLANTATION. THE PORT WAS EXPLANTED AND THE USER DISCOVERED THAT THE PORT MEMBRANE HAD DETACHED FROM THE PORT CHAMBER. THE USER HAD PREVIOUSLY NOTICED THAT THE PORT WAS OBVIOUSLY OCCLUDED. ACCORDING TO THE USER, A SYRINGE SMALLER THAN 2 ML WAS USED TO FLUSH THE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821154 TITA JET LIGHT TITA JET LIGHT II BASIC PUR CONTRACT PXK PFM MEDICAL CPP SA 61.635.83.077 153882000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other