BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 15333906 · Received September 1, 2022

    Report

    Report Number
    3014704491-2022-00385
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    July 30, 2022
    Report Date
    November 28, 2022
    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

    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

    H.6. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2080990. 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, A SAMPLE WAS SUBMITTED TO AID IN OUR INVESTIGATION. MICROSCOPIC INSPECTION WAS NOT ABLE TO IDENTIFY ANY STRUCTURAL DAMAGE TO THE BODY OF THE Q-SYTE. THE SCREW TRACK OF THE Q-SYTE DID CONTAIN A SMALL FLAKE OF NON-FOREIGN MATTER. THE MATERIAL IN QUESTIONS, HAS BEEN POSITIVELY IDENTIFIED AS THE SILICON SEPTUM OF THE Q-SYTE. OUR ENGINEERS CANNOT POSITIVELY IDENTIFY THE ROOT CAUSE AT THIS TIME BUT BELIEVE IT IS RELATED TO THE FEEDING OF THE RAW MATERIAL INTO THE AUTOMATED ASSEMBLY PROCESS. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM ADAPTER WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SCREW MOUTH OF THE ADAPTER CONNECTOR IS DAMAGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM ADAPTER WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SCREW MOUTH OF THE ADAPTER CONNECTOR IS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2404817 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2080990

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown