BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ PROTECTOR P20-O

    MDR report key: 9281980 · Received November 5, 2019

    Report

    Report Number
    3003152976-2019-00764
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    October 16, 2019
    Report Date
    January 7, 2020
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1902153, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. DURING MANUFACTURING, LEAKAGE TESTING IS PERFORMED ON ALL LOTS. TESTING WAS REVIEWED FOR PROTECTOR LOT 1902153, ALL RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MEMBRANE HAD RESIDUE AFTER TRANSFERRING MEDICATION FROM VIAL CAPPED WITH A BD PHASEAL¿ PROTECTOR P20-O. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED MEMBRANE HAD PACLITAXEL RESIDUE AFTER TRANSFERRING PACLITAXEL FROM A VIAL CAPPED WITH AN OPTIMA PROTECTOR P20-0 INTO THE INFUSION ADAPTER C100-0 OF AN INFUSION BAG. PER OPTIMA5 FORM: THE INFUSION ADAPTER C100-0 MEMBRANE HAD PACLITAXEL RESIDUE AFTER TRANSFERRING PACLITAXEL FROM A VIAL CAPPED WITH AN OPTIMA PROTECTOR P20-0 INTO THE INFUSION ADAPTER C100-0 OF AN INFUSION BAG WITH A N35-0 INJECTOR ADDED TO A LUER-LOK SYRINGE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEMBRANE HAD RESIDUE AFTER TRANSFERRING MEDICATION FROM VIAL CAPPED WITH A BD PHASEAL¿ PROTECTOR P20-O. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED MEMBRANE HAD PACLITAXEL RESIDUE AFTER TRANSFERRING PACLITAXEL FROM A VIAL CAPPED WITH AN OPTIMA PROTECTOR P20-0 INTO THE INFUSION ADAPTER C100-0 OF AN INFUSION BAG. PER OPTIMA5 FORM: THE INFUSION ADAPTER C100-0 MEMBRANE HAD PACLITAXEL RESIDUE AFTER TRANSFERRING PACLITAXEL FROM A VIAL CAPPED WITH AN OPTIMA PROTECTOR P20-0 INTO THE INFUSION ADAPTER C100-0 OF AN INFUSION BAG WITH A N35-0 INJECTOR ADDED TO A LUER-LOK SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070958 BD PHASEAL¿ PROTECTOR P20-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1902153 00382905150647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other