BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM (Y LUER WITH PRN AND END CAP)

    MDR report key: 9732463 · Received February 20, 2020

    Report

    Report Number
    8041187-2020-00097
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    January 22, 2020
    Report Date
    February 5, 2020
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 7142466. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. INVESTIGATION CONCLUSION: NO SAME DEFECT COMPLAINT FROM SAME LOT, NO TREND FOR THIS PRODUCT. ROOT CAUSE DESCRIPTION: WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM (Y LUER WITH PRN AND END CAP) 18GA X 1.16IN 1.3MM X 30MM) LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PATIENT UNDERWENT CESAREAN SECTION IN THE FIRST OBSTETRIC AREA. SHE WAS GIVEN A CLOSED ANTI-NEEDLE PUNCTURE VEIN INDWELLING NEEDLE BEFORE THE OPERATION. THE NEEDLE WAS INSERTED UNBLOCKED AND THE BLOOD RETURNED WAS GOOD. WHEN THE STEEL NEEDLE WAS REMOVED, THERE WAS BLEEDING. AFTER THE COTTON SWAB WAS WIPED AND OBSERVED, THE LIQUID ENTERED SMOOTHLY, AND THE SKIN WAS NOT REDNESS AND SWOLLNESS. THE STEEL NEEDLE REMOVAL SITE SLOWLY LEAKED FLUID WHILE DRIPPING UNBLOCKED. THE PREGNANT WOMAN HAD NO COMPLAINTS. OBSERVED THE STEEL NEEDLE REMOVAL SITE FOR CONTINUOUS FLUID LEAKAGE. IMMEDIATELY REMOVED THE INDWELLING NEEDLE AND EXPLAINED TO THE PREGNANT WOMAN. THE SITUATION, TO OBTAIN THE UNDERSTANDING OF PREGNANT WOMEN, AND TO RE-INDWELL THE INDWELLING NEEDLE. THE RESET INDWELLING NEEDLE WAS INTACT AND THERE WAS NO APPEAL. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199721 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM (Y LUER WITH PRN AND END CAP) CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7142466

    Patients

    Seq Age Sex Outcome Treatment
    1 Other