BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    84" PRIMARY SOLUTION SET

    MDR report key: 6661753 · Received June 22, 2017

    Report

    Report Number
    2245270-2017-00032
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    May 23, 2017
    Report Date
    July 10, 2017
    Manufacturer
    VYGON MFG
    Product Code
    FPA
    PMA / PMN Number
    K011336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MALFUNCTIONING DEVICE WAS RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 1

    ONE SAMPLE PRODUCT FOR KS-122-2 WITH UNKNOWN LOT # WAS RETURNED FOR EVALUATION. THE REPORTED COMPLAINT FOR FLUID LEAKING AT JUNCTION BETWEEN TUBING AND DRIP CHAMBER IS CONFIRMED. VISUAL INSPECTION OF THE LEAK LOCATION REVEALED THAT THE BONDING PORT OF THE DRIP CHAMBER IS OVAL, AND THERE IS A LEAK AT THE AREA THAT IS OUT OF ROUND. A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE CONDUCTED FOR THIS PRODUCT SINCE THE LOT # WAS NOT PROVIDED. CORRECTIVE ACTION: AS AN IMMEDIATE ACTION VYGON HAS STOPPED MANUFACTURING WITH DRIP CHAMBERS FROM THIS SUPPLIER, AND CONVERTED ALL PRODUCTION BACK TO THE PREVIOUSLY QUALIFIED SUPPLIER. TRAINING WILL BE PERFORMED WITH ALL OPERATORS PERFORMING BONDING OPERATIONS. A CORRECTIVE ACTION WILL BE ISSUED INTO VYGON USA QUALITY MANAGEMENT SYSTEM TO DOCUMENT THE FORMAL TRAINING. VYGON USA WILL CONTINUE TO MONITOR THIS FAILURE FOR FUTURE OCCURRENCES. IN ADDITION, CAPA (B)(4) HAS BEEN OPENED TO FURTHER INVESTIGATE THE LEAKING DRIP CHAMBER ISSUE.

    Description of Event or Problem · 1

    BOTH GRAVITY AND RATE CONTROL TUBING LEAKING AT JUNCTION BETWEEN TUBING AND DRIP CHAMBER. LEAK NOTICABLE TO THE POINT THAT IT WENT ON PATIENTS ARM DURING GRAVITY INFUSIONS.

    Description of Event or Problem · 1

    BOTH GRAVITY AND RATE CONTROL TUBING LEAKNG AT JUNCTION BETWEEN TUBING AND DRIP CHAMBER. LEAK NOTICABLE TO THE POINT THAT IT WENT ON PATIENTS ARM DURING GRAVITY INFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441331 84" PRIMARY SOLUTION SET INTRAVASCULAR ADMINISTRATION SET FPA VYGON MFG

    Patients

    Seq Age Sex Outcome Treatment
    1