BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS IV CATHETER

    MDR report key: 15992585 · Received December 15, 2022

    Report

    Report Number
    3014704491-2022-00666
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    July 15, 2022
    Report Date
    December 19, 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

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2052641. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS IV CATHETER NEEDLE WAS NOT ABLE TO DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GIVE THE PATIENT INTRAVENOUS INFUSION TO ESTABLISH A VENOUS ACCESS, AND THE NEEDLE CORE CANNOT BE WITHDRAWN AFTER THE PUNCTURE IS SUCCESSFUL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS IV CATHETER NEEDLE WAS NOT ABLE TO DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GIVE THE PATIENT INTRAVENOUS INFUSION TO ESTABLISH A VENOUS ACCESS, AND THE NEEDLE CORE CANNOT BE WITHDRAWN AFTER THE PUNCTURE IS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2777278 BD PEGASUS IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 2052641

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown