BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 8255849 · Received January 17, 2019

    Report

    Report Number
    8041187-2019-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2019
    Date of Event
    December 31, 2018
    Report Date
    February 4, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8235274. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF LEAKAGE OCCURRING IN THIS BATCH OF PEGASUS. 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 MICROSCOPIC INSPECTION OF THE SAMPLE RETURNED ALLOWED OUR ENGINEERS TO IDENTIFY A BREACH IN THE WALL OF THE EXTENSION TUBING. FURTHER INVESTIGATION REVEALED THAT THE DAMAGE WAS MOST LIKELY CAUSE BY INTERACTION WITH A METAL COMPONENT IN THE ADAPTER, EVIDENCE FOR THIS EVENT WAS FOUND THROUGH AN IMPRESSION IN THE METAL HAT IMPLIED THE APPLICATION OF EXCESS FORCE. THIS OCCURS DUE TO MISALIGNMENT IN THE MANUFACTURING MACHINERY RESPONSIBLE FOR FLARING THE END OF THE COMPONENT. TO PREVENT A REOCCURRENCE OF THIS ISSUE WE HAVE INCREASE MAINTENANCE CHECKS AND NOTIFIED THE RESPONSIBLE PERSONNEL OF THIS SITUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM PRN THERE WAS AN ISSUE WITH LEAKAGE AT JOINT OF CONNECTION SITE AND EXTENSION TUBE DURING INFUSION.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WITH THE USE OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM PRN THERE WAS AN ISSUE WITH LEAKAGE AT JOINT OF CONNECTION SITE AND EXTENSION TUBE DURING INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52031 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8235274

    Patients

    Seq Age Sex Outcome Treatment
    1 Other