BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 11168282 · Received January 13, 2021

    Report

    Report Number
    1710034-2021-00025
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 17, 2020
    Report Date
    March 28, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0140771. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF A 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 PROVIDED PHOTOGRAPH OUR ENGINEERS WERE ABLE TO OBSERVE THE MISSING SEPTUM REPORTED TO US BY THE FACILITY. THE SEPTUM WAS MOST LIKELY LOST DURING THE COURSE OF HIGH PRESSURE INJECTION, WHICH CAN OCCUR AS A RESULT OF THE MANUALLY INSERTION OF THE SEPTUM INTO THE ADAPTER BODY. THIS IS CURRENTLY MONITORED BY THE VISUAL INSPECTION OF EVERY DEVICE PRIOR TO PACKAGING; TO PREVENT A REOCCURANCE OF THIS ISSUE WE HAVE ISSUED AN ADVISORY NOTICE TO OUR INSPECTION TEAMS IN ORDER TO RAISE AWARENESS OF THIS KIND OF NON-CONFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM SEPTUM DURING USE, AND IT WAS FOUND THAT THE PART OF IT WAS MISSING AT THE NEEDLE DISENGAGEMENT POINT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE PATIENT NEEDED TO HAVE A CT EXAMINATION THAT MORNING. AFTER THE NURSE SUCCESSFULLY PERFORMED A PEGASUS NEEDLE PUNCTURE ON THE PATIENT, WHEN THE PATIENT WENT TO THE CT ROOM FOR EXAMINATION, BLOOD LEAKAGE WAS FOUND AT THE SEPTUM. AFTER A CAREFUL OBSERVATION REVEALED THAT THE SEPTUM WAS MISSING" "1. THE SAMPLE WAS CONTAMINATED WITH BLOOD. FOR SAFETY REASONS, THE USER HAD DISCARDED IT AND COULDN'T RETURN 2. THE DEFECT PART OF THE SEPTUM MISSING WAS AT THE NEEDLE DISENGAGEMENT POINT, NOT AT THE Q-SYTE END 3. THE BLOOD LEAKAGE WAS HAPPENED AFTER PUNCTURING, AND IT WAS BEFORE THE ANGIOGRAPHY, BUT THE ANGIOGRAPHY HAD NOT PERFORMED YET, SO THERE WAS NO INFLUENCE OF HIGH-PRESSURE INJECTION".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM SEPTUM DURING USE, AND IT WAS FOUND THAT THE PART OF IT WAS MISSING AT THE NEEDLE DISENGAGEMENT POINT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE PATIENT NEEDED TO HAVE A CT EXAMINATION THAT MORNING. AFTER THE NURSE SUCCESSFULLY PERFORMED A PEGASUS NEEDLE PUNCTURE ON THE PATIENT, WHEN THE PATIENT WENT TO THE CT ROOM FOR EXAMINATION, BLOOD LEAKAGE WAS FOUND AT THE SEPTUM. AFTER A CAREFUL OBSERVATION REVEALED THAT THE SEPTUM WAS MISSING" " THE SAMPLE WAS CONTAMINATED WITH BLOOD. FOR SAFETY REASONS, THE USER HAD DISCARDED IT AND COULDN'T RETURN. THE DEFECT PART OF THE SEPTUM MISSING WAS AT THE NEEDLE DISENGAGEMENT POINT, NOT AT THE Q-SYTE END. THE BLOOD LEAKAGE WAS HAPPENED AFTER PUNCTURING, AND IT WAS BEFORE THE ANGIOGRAPHY, BUT THE ANGIOGRAPHY HAD NOT PERFORMED YET, SO THERE WAS NO INFLUENCE OF HIGH-PRESSURE INJECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55142 BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0140771

    Patients

    Seq Age Sex Outcome Treatment
    1