BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS BL 22GA X 0.75IN PRN

    MDR report key: 9534277 · Received December 31, 2019

    Report

    Report Number
    3006948883-2019-01142
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    October 16, 2019
    Report Date
    January 27, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233209. 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, THE ENGINEERS WERE ABLE TO EVALUATE THE EXPANDED TUBING IN THE PHOTOGRAPHS SUBMITTED. BASED ON THE EVALUATION AND DESCRIPTION OF THE EVENT, THEY WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE FORCING OF FLUID THROUGH THE DEVICE DURING INJECTION. THE BD PEGASUS IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS. BD ENCOURAGES THE REVIEW OF THE INSTRUCTIONS FOR USE INCLUDED WITH ALL PEGASUS UNITS; BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE PEGASUS BL 22GA X 0.75IN PRN HAS BEEN FOUND WITH RUPTURED TUBING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, DURING HIGH-PRESSURE INJECTION , IT'S NOTICED THAT THE END OF EXT TUBING (NEAR THE EXT. TUBING) BURST.

    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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE PEGASUS BL 22GA X 0.75IN PRN HAS BEEN FOUND WITH RUPTURED TUBING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, DURING HIGH-PRESSURE INJECTION , IT'S NOTICED THAT THE END OF EXT TUBING (NEAR THE EXT. TUBING) BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331695 PEGASUS BL 22GA X 0.75IN PRN CATHETER FPA BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8233209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other