BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 7237962 · Received February 2, 2018

    Report

    Report Number
    8041187-2018-00012
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    January 10, 2018
    Report Date
    January 16, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: INVESTIGATION SUMMARY NO ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. HOWEVER, PHOTOS WERE RETURNED. UPON INVESTIGATION OF THE PHOTOS, FOREIGN MATTER WAS OBSERVED AT THE PRN OF THE SAMPLES IN THE PHOTOS. A DEVICE HISTORY REVIEW WAS PERFORMED ON LOT 7110497. NO QUALITY NOTIFICATION WAS RAISED FOR SIMILAR NONCONFORMANCES DURING THE PRODUCTION OF THIS BATCH. NO ROOT CAUSE CAN BE DETERMINED AS A SAMPLE WAS RETURNED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INSPECTING A BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM, A "DARK SPOT" WAS FOUND ON THE RUBBER CAP. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82514 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7110497

    Patients

    Seq Age Sex Outcome Treatment
    1 Other