BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS YEL 24GA X 0.75IN PRN-CAP Y

    MDR report key: 10827067 · Received November 12, 2020

    Report

    Report Number
    8041187-2020-00729
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 17, 2020
    Report Date
    January 12, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FPA
    PMA / PMN Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9201967. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEGASUS YEL 24GA X 0.75IN PRN-CAP Y NEEDLE DISENGAGEMENT WAS DIFFICULT AND THE TUBING CLAMP WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. WHEN USING THE PEGASUS, IT WAS FOUND THAT THE HEPARIN CAP FELL OFF, NEEDLE DISENGAGEMENT DIFFICULT, NEEDLE DULL, PINCH CLAMP CAN'T BE CLAMPED WHICH CAUSED SERIOUS ISSUE OF BLOOD RETURN. 2. THE SAMPLES WITH PROBLEMS CANNOT BE RETURNED BECAUSE THEY HAVE BEEN USED, AND NO PHOTOS HAVE BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEGASUS YEL 24GA X 0.75IN PRN-CAP Y NEEDLE DISENGAGEMENT WAS DIFFICULT AND THE TUBING CLAMP WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN USING THE PEGASUS, IT WAS FOUND THAT THE HEPARIN CAP FELL OFF, NEEDLE DISENGAGEMENT DIFFICULT, NEEDLE DULL, PINCH CLAMP CAN'T BE CLAMPED WHICH CAUSED SERIOUS ISSUE OF BLOOD RETURN. THE SAMPLES WITH PROBLEMS CANNOT BE RETURNED BECAUSE THEY HAVE BEEN USED, AND NO PHOTOS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292509 PEGASUS YEL 24GA X 0.75IN PRN-CAP Y INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON MEDICAL (SINGAPORE) 9201967

    Patients

    Seq Age Sex Outcome Treatment
    1