BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARKER FLEX-TIP

    MDR report key: 18196865 · Received November 22, 2023

    Report

    Report Number
    3000219639-2023-00040
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    October 24, 2023
    Report Date
    July 23, 2024
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    UDI-DI
    10749065011657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS A DELAY IN INTUBATION AND VENTILATION. THE COMPLAINT OF "TUBING KINK RIGHT ABOVE THE PILOT BALLOON" REGARDING PART H-PFHV-65-10 WAS NOT CONFIRMED. THE ROOT CAUSE CANNOT BE DETERMINED BUT COULD POSSIBLY BE A RESULT OF THE TUBING THICKNESS BEING TOO THIN. A RISK ASSESSMENT WAS PERFORMED USING RMA-20024B, REV 1 AND THE SEVERITY RATING WAS DETERMINED TO BE 7/10 WHICH DOES NOT REQUIRE THE INITIATION OF A CAPA. THERE HAVE BEEN 4 OTHER COMPLAINTS AGAINST H/I-PFHV-65 IN THE PAST 24 MONTHS. 0 OF THOSE COMPLAINTS WERE REGARDING TUBING KINKS. AN INVENTORY EVALUATION OF THIS LOT WAS COMPLETED BUT NO NON-CONFORMANCES WERE FOUND. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    THIS WAS A DELAY IN INTUBATION AND VENTILATION. THE COMPLAINT OF "TUBING KINK RIGHT ABOVE THE PILOT BALLOON" REGARDING PART H-PFHV-65-10 WAS NOT CONFIRMED. THE ROOT CAUSE CANNOT BE DETERMINED BUT COULD POSSIBLY BE A RESULT OF THE TUBING THICKNESS BEING TOO THIN. A RISK ASSESSMENT WAS PERFORMED USING RMA-20024B, REV 1 AND THE SEVERITY RATING WAS DETERMINED TO BE 7/10 WHICH DOES NOT REQUIRE THE INITIATION OF A CAPA. THERE HAVE BEEN 4 OTHER COMPLAINTS AGAINST H/I-PFHV-65 IN THE PAST 24 MONTHS. 0 OF THOSE COMPLAINTS WERE REGARDING TUBING KINKS. AN INVENTORY EVALUATION OF THIS LOT WAS COMPLETED BUT NO NON-CONFORMANCES WERE FOUND. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. **UDI RELATED DATA QUALITY UPDATES ONLY**

    Additional Manufacturer Narrative · 0

    THIS WAS A DELAY IN INTUBATION AND VENTILATION.

    Description of Event or Problem · 0

    TUBING GOT A KINK RIGHT ABOVE THE PILOT BALLOON ALMOST CAUSING THE PATIENT TO CODE DUE TO NOT BEING ABLE TO VENTILATE.

    Description of Event or Problem · 0

    TUBING GOT A KINK RIGHT ABOVE THE PILOT BALLOON ALMOST CAUSING THE PATIENT TO CODE DUE TO NOT BEING ABLE TO VENTILATE.

    Description of Event or Problem · 0

    TUBING GOT A KINK RIGHT ABOVE THE PILOT BALLOON ALMOST CAUSING THE PATIENT TO CODE DUE TO NOT BEING ABLE TO VENTILATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041192 PARKER FLEX-TIP ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 6.5MM BTR PARKER MEDICAL H-PFHV-65 2304HV1Q47J 10749065011657

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention