BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 8244417 · Received January 14, 2019

    Report

    Report Number
    3006948883-2018-00414
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    December 24, 2018
    Report Date
    January 2, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903839124
    PMA / PMN Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233186. OUR RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED FROM 9/10/2018-9/12/2018, AND DETERMINED THAT THIS IS THE ONLY INSTANCE OF A FOREIGN MATERIAL BEING OBSERVED IN THIS BATCH OF PEGASUS. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. INVESTIGATION CONCLUSION: QUALITY ENGINEERS REVIEWED THE DEVICE SUBMITTED BY THE FACILITY. THEY FOUND A PARTICULATE NEAR THE TIP OF THE CANNULA, MICROSCOPIC INSPECTION DETERMINED THAT THE COLOR OF THE FOREIGN MATERIAL WAS BRIGHT YELLOW THAT IS CONSISTENT WITH THE PLASTIC USED IN THE FORMATION OF THE CATHETER HUB. DURING THE MOLDING PROCESS IT IS POSSIBLE FOR SMALL PARTICLES TO FORM AND BREAK OFF OF THE MANUFACTURING EQUIPMENT. ROOT CAUSE DESCRIPTION: OPERATORS ARE EXPECTED TO INSPECT AND CLEAN THIS DEBRIS FROM THE PEGASUS DEVICES PRIOR TO THE RELEASE OF THE PRODUCT FOR USE. TO PREVENT THE REOCCURRENCE OF THIS ISSUE WE HAVE CONDUCTED A RETRAINING OF THE PERSONNEL RESPONSIBLE FOR THIS TASK. RATIONALE: BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM THERE WAS A WHITE SPOT ON THE CATHETER TUBING AFTER NEEDLE COVER WAS REMOVED BEFORE THE PENETRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38026 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8233186 00382903839124

    Patients

    Seq Age Sex Outcome Treatment
    1 Other