BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 16907186 · Received May 10, 2023

    Report

    Report Number
    3014704491-2023-00179
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    March 28, 2023
    Report Date
    May 12, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2082656. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM TUBING CLAMP IS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023, THE NURSE USED THE INTRAVENOUS INDWELLING NEEDLE AND FOUND THAT IT WAS LOCKED AND STILL RETURNING BLOOD, SO SHE REPLACED IT IN TIME AND NOTIFIED THE EQUIPMENT DEPARTMENT TO DEAL WITH IT, AND NO ADVERSE EFFECTS WERE CAUSED TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM TUBING CLAMP IS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2023, THE NURSE USED THE INTRAVENOUS INDWELLING NEEDLE AND FOUND THAT IT WAS LOCKED AND STILL RETURNING BLOOD, SO SHE REPLACED IT IN TIME AND NOTIFIED THE EQUIPMENT DEPARTMENT TO DEAL WITH IT, AND NO ADVERSE EFFECTS WERE CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232061 BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2082656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown