BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA PROTECTOR (P20-O)

    MDR report key: 9225358 · Received October 23, 2019

    Report

    Report Number
    3003152976-2019-00739
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    October 8, 2019
    Report Date
    December 20, 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
    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 THE BD PHASEAL OPTIMA PROTECTOR (P20-O) EXPERIENCED LEAKAGE AROUND/THROUGH THE MEMBRANE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515064 BATCH NO: UNKNOWN. EVENT DESCRIPTION: HAD ISSUES WITH OPTIMA ITEM NUMBER: 515064. THEY REPORTED LEAKAGE ON THE MEMBRANES OF THIS ITEM WHEN DISCONNECTING WHILE COMPOUNDING DRUG. ADDITIONALLY THEY REPORTED THAT THE INJECTOR CAME OFF OF THE SYRINGE WHILE COMPOUNDING AND WAS "BROKEN". THEY SAID THAT THEY WERE UNSURE WHETHER THE TECHNICIAN WAS HOLDING THE HUB.

    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 THE BD PHASEAL OPTIMA PROTECTOR (P20-O) EXPERIENCED LEAKAGE AROUND/THROUGH THE MEMBRANE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515064 BATCH NO: UNKNOWN. EVENT DESCRIPTION: HAD ISSUES WITH OPTIMA ITEM NUMBER: 515064. THEY REPORTED LEAKAGE ON THE MEMBRANES OF THIS ITEM WHEN DISCONNECTING WHILE COMPOUNDING DRUG. ADDITIONALLY THEY REPORTED THAT THE INJECTOR CAME OFF OF THE SYRINGE WHILE COMPOUNDING AND WAS "BROKEN". THEY SAID THAT THEY WERE UNSURE WHETHER THE TECHNICIAN WAS HOLDING THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025329 BD PHASEAL OPTIMA PROTECTOR (P20-O) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1902153 00382905150647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other