BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS BL 22GA X 1.00IN PRN-CAP Y

    MDR report key: 15874943 · Received November 28, 2022

    Report

    Report Number
    8041187-2022-00686
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    November 1, 2022
    Report Date
    January 9, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    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 AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2082677. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THE AFFECTED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PEGASUS BL 22GA X 1.00IN PRN-CAP Y LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE HEAD NURSE OF THE EMERGENCY DEPARTMENT IMPLANTED THE INDWELLING NEEDLE TO THE PATIENT FOR INFUSION, SHE FOUND THAT THE EXTENSION TUBE CLIPPED BY THE INFUSION CLIP WAS LEAKING FLUID.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING PEGASUS BL 22GA X 1.00IN PRN-CAP Y LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE HEAD NURSE OF THE EMERGENCY DEPARTMENT IMPLANTED THE INDWELLING NEEDLE TO THE PATIENT FOR INFUSION, SHE FOUND THAT THE EXTENSION TUBE CLIPPED BY THE INFUSION CLIP WAS LEAKING FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112824 PEGASUS BL 22GA X 1.00IN PRN-CAP Y INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2082677

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown