BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 8019494 · Received October 30, 2018

    Report

    Report Number
    8041187-2018-00390
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 7, 2018
    Report Date
    November 30, 2018
    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

    A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 7083016. OUR RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED IN APRIL OF 2017, AND DETERMINED THAT THIS IS THE ONLY INSTANCE OF A FOREIGN MATERIAL APPEARING IN THIS BATCH OF PRODUCT. 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 OF PACKAGED GOODS. VISUAL OBSERVATION OF THE PROVIDED SAMPLE WAS SUFFICIENT TO IDENTIFY THE NONCONFORMANCE, AND WE HAVE CONTACTED OUR SUPPLIER REGARDING THIS ISSUE. THEY WERE ABLE TO CONFIRM, BASED ON THEIR TESTING RESULTS, THAT THE ROOT CAUSE FOR THIS EVENT IS VARIANCE IN THE RAW MATERIALS USED IN THE MANUFACTURE OF THE SLEEVE STOPPER. TO COMBAT THE REOCCURRENCE OF THIS EVENT BD HAS OPTIMIZED OUR INSPECTION STATIONS, AND NOTIFIED THE APPROPRIATE PERSONNEL OF THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    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 THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861618 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7083016

    Patients

    Seq Age Sex Outcome Treatment
    1 Other