BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 8612772 · Received May 15, 2019

    Report

    Report Number
    8041187-2019-00372
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    April 25, 2019
    Report Date
    June 25, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    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 7083019. 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. BASED ON THE SAMPLE SUBMITTED, BD ENGINEERS WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS ISSUE IS AN ANOMALY IN THE FABRICATION PROCESS OF THE RAW MATERIAL USED FOR THE CATHETER TUBING. THE ABRASIVE MARKINGS FOUND ON THE DEVICE OCCUR SPORADICALLY DURING THE EXTRUDING PROCESS AND ARE CONTROLLED THROUGH VISUAL SORTING OF THE MATERIAL DURING RECEIPT FROM THE SUPPLIER.

    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: EVENT DATE: (B)(6) 2019 IT'S FOUND THAT THERE WAS LEAKAGE ON THE JOINT OF THE CATHETER AND CATHETER HUB IN THE FLUSHING AFTER THE NEEDLE WAS RETRACTED. THE LEAKAGE WAS NOT FOUND IN THE PENETRATION. THE CATHETER WAS REMOVED IMMEDIATELY.

    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: EVENT DATE: (B)(6) 2019 IT'S FOUND THAT THERE WAS LEAKAGE ON THE JOINT OF THE CATHETER AND CATHETER HUB IN THE FLUSHING AFTER THE NEEDLE WAS RETRACTED. THE LEAKAGE WAS NOT FOUND IN THE PENETRATION. THE CATHETER WAS REMOVED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403954 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7083019

    Patients

    Seq Age Sex Outcome Treatment
    1 Other