BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ OPTIMA PROTECTOR (P20-O)

    MDR report key: 8651636 · Received May 29, 2019

    Report

    Report Number
    3003152976-2019-00357
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    May 10, 2019
    Report Date
    July 9, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150647
    PMA / PMN Number
    K181221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1807704, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES BOTH VISUAL AND FUNCTIONAL TESTING DURING MANUFACTURING TO ENSURE THE FUNCTIONALITY OF THE DEVICE, FLOW RATE AMONG SOME OF THE TESTING PERFORMED. THREE RETAINED SAMPLES OF THE PROTECTOR LOT 1807704 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 THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FLOW ISSUES OCCURRED WITH A BD PHASEAL¿ OPTIMA PROTECTOR (P20-O). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW DIFFICULT IT IS TO EXTRACT THE DRUG FROM VIALS AND PUSH INTO IV BAG EVENT DESCRIPTION PER ATTACHED EMAIL STATES, "PUSH AND PULL FORCE DURING EXTRACTION IS NOT EASY (X7 INCIDENTS): ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW IT IS TO EXTRACT DRUG FROM VIALS AND PUSH INTO IV BAG. TECHS ARE USED TO EXTRACTING WITH EASE SINCE THEY USED 16 GAUGE NEEDLE, THEY NOTICED THE DIFFERENCE WITH PHASEAL SINCE THEY ARE USING FOR CISPLATIN. COMPONENT USED P20-O LOT NUMBER 187704 AND N35-O LOT NUMBER 1807712."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THAT FLOW ISSUES OCCURRED WITH A BD PHASEAL¿ OPTIMA PROTECTOR (P20-O). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW DIFFICULT IT IS TO EXTRACT THE DRUG FROM VIALS AND PUSH INTO IV BAG EVENT DESCRIPTION PER ATTACHED EMAIL STATES, "PUSH AND PULL FORCE DURING EXTRACTION IS NOT EASY (X7 INCIDENTS): ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW IT IS TO EXTRACT DRUG FROM VIALS AND PUSH INTO IV BAG. TECHS ARE USED TO EXTRACTING WITH EASE SINCE THEY USED 16 GAUGE NEEDLE, THEY NOTICED THE DIFFERENCE WITH PHASEAL SINCE THEY ARE USING FOR CISPLATIN. COMPONENT USED P20-O LOT NUMBER 187704 AND N35-O LOT NUMBER 1807712."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444446 BD PHASEAL¿ OPTIMA PROTECTOR (P20-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1807704 00382905150647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other