BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 8236411 · Received January 10, 2019

    Report

    Report Number
    8041187-2018-00520
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 25, 2018
    Report Date
    February 5, 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

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 7233334. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF DAMAGED TUBING 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 THE SAMPLE PROVIDED FOR EVALUATION CLEARLY EXHIBITED A LARGE WOUND IN THE WALL OF THE EXTENSION TUBING. OUR ENGINEERS NOTED THAT THE WOUND HAD CHARACTERISTICS CONSISTENT WITH LARGE FORCE MOVING FROM THE INTERIOR OF THE TUBING, TO THE EXTERIOR. THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE USE OF A HIGH PRESSURE INJECTION THAT EXCEED PRODUCT SPECIFICATIONS. PLEASE NOTE THAT THE PEGASUS IS NOT RATED FOR INJECTION, AND SHOULD BE USED FOR INFUSION ONLY PROCEDURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM EXTENSION TUBE WAS BROKEN DURING HIGH-PRESSURE INJECTION WHILE DOING A CT EXAMINATION AND BLOOD SPURTED ON THE PATIENT AND NO ONE ELSE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE OTHER: (B)(6). 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 EXTENSION TUBE WAS BROKEN DURING HIGH-PRESSURE INJECTION WHILE DOING A CT EXAMINATION AND BLOOD SPURTED ON THE PATIENT AND NO ONE ELSE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26392 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7233334

    Patients

    Seq Age Sex Outcome Treatment
    1 Other