BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS PNK 20GA X 1.16IN PRN

    MDR report key: 19056943 · Received April 7, 2024

    Report

    Report Number
    3002601200-2024-00124
    Event Type
    Malfunction
    Date Received
    April 7, 2024
    Date of Event
    March 12, 2024
    Report Date
    April 18, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 3170899. 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. SKU#383941 IS PEGASUS DEVICE (PVC EXTENSION TUBING), THE INTENDED USE FOR THE BD PEGASUS DEVICE IS THE INTRAVASCULAR ADMINISTRATION OF FLUIDS. THE PRODUCT IS USED UNDER HIGH PRESSURE, USE OF THIS PRODUCT WITH POWER INJECTORS WILL CAUSE CATHETER LEAKAGE OR PRODUCT DAMAGE. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED TO BE RELATED TO PRODUCT QUALITY.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS PNK 20GA X 1.16IN PRN LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT FOR "SLURRED SPEECH, LEFT LIMB WEAKNESS FOR 1 HOUR" HEAD CTA EXAMINATION, (B)(6) 2024 20:44 HIGH-PRESSURE INJECTION OF DRUGS, THE USE OF THE CLOSED ANTI-NEEDLE PUNCTURE WOUND INTRAVENOUS NEEDLE, INJECTION PROCESS, NO MEDICINE INTO THE BODY, PAUSE AFTER THE EXAMINATION FOUND THAT THE NEEDLE NEEDLE NEEDLE BURST, THE MEDICINE AND BLOOD LEAKED OUT OF THE BODY. THE TUBE WAS REMOVED AND REPLACED, AND THE EXAMINATION WAS COMPLETED AT 20:58.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071174 BD PEGASUS PNK 20GA X 1.16IN PRN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 3170899

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown