BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS GN 18GA X 1.16IN PRN

    MDR report key: 14060453 · Received April 8, 2022

    Report

    Report Number
    3014704491-2022-00132
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 16, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 04-APR-2022. H.6. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1230464. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. 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. ADDITIONALLY, A FULLY ACTIVATED DEVICE WAS SUBMITTED TO AID IN OUR INVESTIGATION. UNFORTUNATELY, DUE TO THE ACTIVATED SAFETY MECHANISM OUR ENGINEERS WERE UNABLE TO TEST THIS SPECIFIC DEVICE FOR DISENGAGEMENT PERFORMANCE; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED BD PEGASUS GN 18GA X 1.16IN PRN HAD DIFFICULT NEEDLE DISENGAGEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE USER IS PREPARING TO WITHDRAW THE NEEDLE, IT IS DIFFICULT TO WITHDRAW THE NEEDLE CORE."

    Description of Event or Problem · 0

    IT WAS REPORTED BD PEGASUS GN 18GA X 1.16IN PRN HAD DIFFICULT NEEDLE DISENGAGEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE USER IS PREPARING TO WITHDRAW THE NEEDLE, IT IS DIFFICULT TO WITHDRAW THE NEEDLE CORE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159790 BD PEGASUS GN 18GA X 1.16IN PRN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1230464

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown