BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    105" IV ADMINISTRATION SET

    MDR report key: 6603042 · Received May 31, 2017

    Report

    Report Number
    2245270-2017-00025
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    April 18, 2017
    Report Date
    June 26, 2017
    Manufacturer
    VYGON MFG
    Product Code
    FPA
    PMA / PMN Number
    K011336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 BN-602, LOT# 1607093D WAS RETURNED FOR EVALUATION. THE PRODUCT WAS LEAK TESTED. THE COMPLAINT FOR FLUID LEAK WHERE THE TUBING MEETS THE DRIP CHAMBER WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD WAS CONDUCTED FOR THIS PRODUCT WITH THE LOT NUMBER PROVIDED. THE QC INSPECTION REPORT INDICATES ZERO FINDINGS FOR LEAK TESTING DURING THIS LOT MANUFACTURED IN AUGUST 2016. ALL PRODUCTION AND QC PERSONNEL ARE UP TO DATE WITH THEIR TRAINING. 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, (B)(4) HAS BEEN OPENED TO FURTHER INVESTIGATE THE LEAKING DRIP CHAMBER ISSUE.

    Description of Event or Problem · 1

    DRIP SET UP & TUBING WAS LEAKING JUST BELOW THE DRIP CHAMBER WHERE THE TUBING MEETS THE DRIP CHAMBER.

    Description of Event or Problem · 1

    DRIP SET UP AND TUBING WAS LEAKING JUST BELOW THE DRIP CHAMBER WHERE THE TUBING MEETS THE DRIP CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383731 105" IV ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA VYGON MFG BN-602 1607093D

    Patients

    Seq Age Sex Outcome Treatment
    1