BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 12500048 · Received September 20, 2021

    Report

    Report Number
    3006948883-2021-00919
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    August 23, 2021
    Report Date
    October 17, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES . D.9. RETURNED TO MANUFACTURER ON: 8/31/2021. H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1110742. 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 SAMPLE THAT WAS SUBMITTED BY THE FACILITY, HAS BEEN REVIEWED BY OUR TEAM OF QUALITY ENGINEERS. FUNCTIONAL TESTING OF THE DEVICE IDENTIFIED A LEAK, WHICH ORIGINATED FROM THE CATHETER TUBING. CLOSER INSPECTION OF THE WOUNDED REGION IDENTIFIED A SMALL V-SHAPED PUNCTURE MARK. THIS V-SHAPE IS INDICATIVE OF A NEEDLE-PIERCE-THROUGH. ALTHOUGH IT IS POSSIBLE TO PRODUCE THIS TYPE OF DAMAGE DURING MANUFACTURING; IT IS MONITORED AND CONTROLLED USING AN AUTOMATED VISUAL SYSTEM, AND THE RESULTING PRODUCT WOULD NOT HAVE BEEN ABLE TO BE SUCCESSFULLY INTUBATED. BASED ON THESE OBSERVATIONS, OUR ENGINEERS WERE NOT ABLE ASSOCIATE THIS COMPLAINT WITH THE MANUFACTURING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE RESPIRATORY DEPARTMENT REPORTED FLUID LEAKAGE WAS AT THE ROOT OF THE TUBE WHEN THE INDWELLING NEEDLE WAS SUCCESSFULLY PUNCTURED AND THE NEEDLE 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¿ SAFETY CLOSED IV CATHETER SYSTEM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE RESPIRATORY DEPARTMENT REPORTED FLUID LEAKAGE WAS AT THE ROOT OF THE TUBE WHEN THE INDWELLING NEEDLE WAS SUCCESSFULLY PUNCTURED AND THE NEEDLE WAS REMOVED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396086 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1110742

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown