BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ IV CATHETER

    MDR report key: 8632628 · Received May 22, 2019

    Report

    Report Number
    3006948883-2019-00396
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    May 6, 2019
    Report Date
    June 14, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233182. 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. ADDITIONALLY THE FOREIGN MATERIAL ON THE SUBMITTED DEVICE WAS IDENTIFIED AS A PART OF THE TIP-SHIELD COMPONENT BY USING COMPOSITION TESTING. THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS CONTACT WITH THE MACHINERY AS A RESULT OF INADEQUATE ALIGNMENT DURING MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS¿ IV CATHETER HAD FOREIGN MATTER STUCK ON THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DATE: (B)(6) 2019. IT'S FOUND THAT THERE WAS YELLOW FOREIGN MATTER STUCK ON THE CATHETER AFTER THE NEEDLE COVER WAS REMOVED.

    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 WAS REPORTED THAT BD PEGASUS¿ IV CATHETER HAD FOREIGN MATTER STUCK ON THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT DATE: (B)(6) 2019 IT'S FOUND THAT THERE WAS YELLOW FOREIGN MATTER STUCK ON THE CATHETER AFTER THE NEEDLE COVER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427949 BD PEGASUS¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8233182

    Patients

    Seq Age Sex Outcome Treatment
    1 Other