BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 9460086 · Received December 12, 2019

    Report

    Report Number
    3006948883-2019-01080
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    November 8, 2019
    Report Date
    December 17, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050899. 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. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. 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 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM HAD FOREIGN MATTER ON THE NEEDLE TIP. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT UNDERWENT GASTRIC TUMOR RESECTION IN THE OPERATING ROOM ON (B)(6) 2019. BEFORE THE OPERATION, THE NURSE USED THE INDWELLING NEEDLE FOR THE PATIENT'S INTRAVENOUS INFUSION AS INSTRUCTED BY THE DOCTOR, AFTER UNWRAPPED THE PACKAGE, AND NURSE FOUND A GAUZE PARCEL ON THE NEEDLE TIP, AND IMMEDIATELY REPLACED IT.

    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¿ SAFETY CLOSED IV CATHETER SYSTEM HAD FOREIGN MATTER ON THE NEEDLE TIP. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT UNDERWENT GASTRIC TUMOR RESECTION IN THE OPERATING ROOM ON (B)(6) 2019. BEFORE THE OPERATION, THE NURSE USED THE INDWELLING NEEDLE FOR THE PATIENT'S INTRAVENOUS INFUSION AS INSTRUCTED BY THE DOCTOR, AFTER UNWRAPPED THE PACKAGE, AND NURSE FOUND A GAUZE PARCEL ON THE NEEDLE TIP, AND IMMEDIATELY REPLACED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258149 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM N/A FOZ BD (SUZHOU) 9050899

    Patients

    Seq Age Sex Outcome Treatment
    1 Other