BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 15234299 · Received August 16, 2022

    Report

    Report Number
    3014704491-2022-00355
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    June 24, 2022
    Report Date
    September 1, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CORRECTION: H1: DEVICE EVAL BY MANUFACTURER?: NO. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1053329. 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, VISUAL ANALYSIS WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RETAINED DEVICES WERE FOUND TO BE FREE OF ANY DAMAGE OR OTHER ABNORMALITIES. 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 THERE WAS WHITE FOREIGN MATTER FOUND IN THE CATHETER TUBE OF THE INDWELLING OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM BEFORE STARTING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE FOUND WHITE FLOC IN THE CATHETER TUBE OF INDWELLING NEEDLE WHEN PREPARING MATERIALS FOR THE TREATMENT OF THE PATIENT, AND IMMEDIATELY REPLACED IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS WHITE FOREIGN MATTER FOUND IN THE CATHETER TUBE OF THE INDWELLING OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM BEFORE STARTING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE FOUND WHITE FLOC IN THE CATHETER TUBE OF INDWELLING NEEDLE WHEN PREPARING MATERIALS FOR THE TREATMENT OF THE PATIENT, AND IMMEDIATELY REPLACED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509657 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 1053329

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown