BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA INJECTOR N35-O

    MDR report key: 17322389 · Received July 13, 2023

    Report

    Report Number
    3003152976-2023-00286
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 22, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150524
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2210309, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL INSPECTIONS PRIOR TO RELEASE, INCLUDING VERIFICATION THE PRODUCT IS NOT DAMAGED, FLOW RATE, AND ALL CRITICAL DIMENSIONS MEET SPECIFICATIONS. UPON REVIEWING THE RESULTS FOR LOT 2210309, NO ISSUES WERE IDENTIFIED DURING TESTING AND THE PRODUCT MET THE REQUIRED CRITERIA FOR RELEASE. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE SAMPLES WERE FUNCTIONALLY TESTED AND, IN ALL CASES, FLOW WAS OBSERVED AND THE PRODUCT FUNCTIONED AS INTENDED. BASED ON OUR INVESTIGATION AND SAMPLE EVALUATION, WE CANNOT IDENTIFY A ROOT CAUSE AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ OPTIMA INJECTOR N35-O THERE WERE FLOW ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: XXX REACHED OUT TO JEFF LAUGHMAN AND MYSELF REGARDING CONCERNS RELATED TO GIVING AN IVP HAZARDOUS DRUG USING THE OPTIMA CSTD AND THE ALARIS TEXIUM IV SET. THEY STATED THAT THEIR PRACTICE FOR ADMINISTRATION OF AN IVP VIA THIS TEXIUM SET HAS NOT CHANGED DURING THIS TRIAL WITH OPTIMA BEING USED AT THE DISTAL ACCESS PORT OF THE SET FOR AN IVP. PRIOR TO OPTIMA THEY USED A TEXIUM BONDED IVP SYRINGE FOR ADMINISTRATION. XXX REACHED OUT TO THE PRIMARY RN FOR THE EXACT DETAILS. THIS IS WHAT THEY STATED, ¿I NOTICED THE DRIP RATE HAD SLOWED DOWN AND WHEN I STARTED PUSHING THE DRUG, THE DRIP HAD COMPLETELY STOPPED AND THE DRUG WOULD STARTING BACK UP THE Y-SITE TOWARDS THE PUMP. I DIDN¿T DO THE PINCH LINE METHOD FOR THIS BECAUSE OF HOW SLOW THE CARRIER FLUID WAS FLOWING. ONCE THE LINE WAS SLIGHTLY CLEAR, I WOULD THEN PINCH THE LINE AND CHECK FOR BLOOD RETURN. WITH THE SECOND SYRINGE, I NOTICED THE PRESSURE TO PUSH THE DRUG WOULD INCREASE WHEN THE SYRINGE WAS CLOSE TO BEING HALFWAY EMPTY (LIKE MAYBE 10MLS LEFT). AT ONE POINT, I PUSHED THE DRUG A LITTLE TOO HARD AND THE PATIENT REPORTED FEELING PRESSURE AT HIS PORT SITE. THE PATIENT¿S PORT SITE WAS ASSESSED AND DRUG/FLUID WAS NOT NOTED BUT THEY DID REPORT THE SENSATION OF FEELING SOMETHING WET. WITH THE LAST TWO SYRINGES, WE DECIDED TO RUN THE CARRIER FLUID THROUGH THE PUMP AT 250MLS/HR AND WOULD PAUSE THE PUMP AND CHECK BLOOD RETURN USING THAT METHOD.¿

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ OPTIMA INJECTOR N35-O THERE WERE FLOW ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) REACHED OUT TO (B)(6) AND MYSELF REGARDING CONCERNS RELATED TO GIVING AN IVP HAZARDOUS DRUG USING THE OPTIMA CSTD AND THE ALARIS TEXIUM IV SET. THEY STATED THAT THEIR PRACTICE FOR ADMINISTRATION OF AN IVP VIA THIS TEXIUM SET HAS NOT CHANGED DURING THIS TRIAL WITH OPTIMA BEING USED AT THE DISTAL ACCESS PORT OF THE SET FOR AN IVP. PRIOR TO OPTIMA THEY USED A TEXIUM BONDED IVP SYRINGE FOR ADMINISTRATION. (B)(6) REACHED OUT TO THE PRIMARY RN FOR THE EXACT DETAILS. THIS IS WHAT THEY STATED, ¿I NOTICED THE DRIP RATE HAD SLOWED DOWN AND WHEN I STARTED PUSHING THE DRUG, THE DRIP HAD COMPLETELY STOPPED AND THE DRUG WOULD STARTING BACK UP THE Y-SITE TOWARDS THE PUMP. I DIDN¿T DO THE PINCH LINE METHOD FOR THIS BECAUSE OF HOW SLOW THE CARRIER FLUID WAS FLOWING. ONCE THE LINE WAS SLIGHTLY CLEAR, I WOULD THEN PINCH THE LINE AND CHECK FOR BLOOD RETURN. WITH THE SECOND SYRINGE, I NOTICED THE PRESSURE TO PUSH THE DRUG WOULD INCREASE WHEN THE SYRINGE WAS CLOSE TO BEING HALFWAY EMPTY (LIKE MAYBE 10MLS LEFT). AT ONE POINT, I PUSHED THE DRUG A LITTLE TOO HARD AND THE PATIENT REPORTED FEELING PRESSURE AT HIS PORT SITE. THE PATIENT¿S PORT SITE WAS ASSESSED AND DRUG/FLUID WAS NOT NOTED BUT THEY DID REPORT THE SENSATION OF FEELING SOMETHING WET. WITH THE LAST TWO SYRINGES, WE DECIDED TO RUN THE CARRIER FLUID THROUGH THE PUMP AT 250MLS/HR AND WOULD PAUSE THE PUMP AND CHECK BLOOD RETURN USING THAT METHOD.¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692752 BD PHASEAL¿ OPTIMA INJECTOR N35-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515052 2210309 00382905150524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown