BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA PROTECTOR (P20-O MULTI)

    MDR report key: 12140354 · Received July 8, 2021

    Report

    Report Number
    3003152976-2021-00373
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    June 9, 2021
    Report Date
    August 2, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150654
    PMA / PMN Number
    K181221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THREE PHOTOS WHICH DISPLAY THE PROTECTOR ATTACHED TO A VIAL WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PHOTOS, NO FRAGMENTS OR SHINE CAN BE OBSERVED ON THE MEMBRANE OF THE PRODUCT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT PROTECTOR LOTS 2103406 AND 2101402, ALONG WITH INJECTOR LOT 2010801, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THESE ISSUES. FRAGMENTATION TESTING IS PERFORMED DURING MANUFACTURING TO EVALUATE ANY PARTICULATES GENERATED AFTER TEN ACTIVATIONS. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. FOUR RETAINED SAMPLES OF EACH REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE OBSERVED ON ANY OF THE PRODUCT. FUNCTIONAL TESTING WAS ALSO PERFORMED, PENETRATING THE PROTECTORS FROM LOT 2101402 AND 2103406 WITH SAMPLE INJECTORS FROM LOT 2010801 TEN TIMES. IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO FRAGMENTATION WAS IDENTIFIED. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SMALL PIECE OF LOOSE "MEMBRANE" WAS FOUND ATOP THE BD PHASEAL¿ OPTIMA PROTECTOR (P20-O MULTI) MEMBRANE DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY NOTICED TINY PIECE (GRAIN OF SAND SIZE) OF LOOSE MEMBRANE MATERIAL (OR SOMETHING?) SITTING ON TOP OF P20-O PHASEAL OPTIMA PROTECTOR MEMBRANE WHEN DISCONNECTING THE INJECTOR AFTER DRAWING UP DRUG. I, THE REP SAW IT TOO. THIS HAPPENED 4 TIMES. ALL THE INJECTORS CAME FROM THE SAME MULTIPACK PACKAGE - ¿ ETOPOSIDE ¿ TINY PIECE OF MEMBRANE OBSERVED ON TOP OF C100 PROTECTOR MEMBRANE AFTER DRAWING UP MEDICATION. ¿ IRINOTECAN ¿ 4 VIALS. PROTECTOR AND INJECTOR ON VIAL #4 HAVE SMALL VISIBLE HOLES FROM INJECTOR NEEDLE. AGAIN, A TINY PIECE OF MEMBRANE OBSERVED ON TOP OF PROTECTOR MEMBRANE. ¿ VELCADE ¿ SUBQ SYRINGE. AGAIN, A TINY PIECE OF MEMBRANE OBSERVED ON TOP OF PROTECTOR MEMBRANE. ¿ ALIMTA ¿ 5 VIALS / RECONSTITUTED POWDER. FIRST ACCESS TO DILUENT BOTTLE HAD A TINY PIECE OF MEMBRANE OBSERVED ON TOP OF PROTECTOR MEMBRANE. ADAPTER MEMBRANE ON BAG HAD A LOT OF SHINE AFTER DRUG WAS ADDED WITH THE INJECTOR THAT HAD BEEN ENGAGED 6 TIMES AT THIS POINT."

    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 A SMALL PIECE OF LOOSE "MEMBRANE" WAS FOUND ATOP THE BD PHASEAL¿ OPTIMA PROTECTOR (P20-O MULTI) MEMBRANE DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY NOTICED TINY PIECE (GRAIN OF SAND SIZE) OF LOOSE MEMBRANE MATERIAL (OR SOMETHING?) SITTING ON TOP OF P20-O PHASEAL OPTIMA PROTECTOR MEMBRANE WHEN DISCONNECTING THE INJECTOR AFTER DRAWING UP DRUG. I, THE REP SAW IT TOO. THIS HAPPENED 4 TIMES. ALL THE INJECTORS CAME FROM THE SAME MULTIPACK PACKAGE. ETOPOSIDE ¿ TINY PIECE OF MEMBRANE OBSERVED ON TOP OF C100 PROTECTOR MEMBRANE AFTER DRAWING UP MEDICATION. IRINOTECAN ¿ 4 VIALS. PROTECTOR AND INJECTOR ON VIAL #4 HAVE SMALL VISIBLE HOLES FROM INJECTOR NEEDLE. AGAIN, A TINY PIECE OF MEMBRANE OBSERVED ON TOP OF PROTECTOR MEMBRANE. VELCADE ¿ SUBQ SYRINGE. AGAIN, A TINY PIECE OF MEMBRANE OBSERVED ON TOP OF PROTECTOR MEMBRANE. ALIMTA ¿ 5 VIALS / RECONSTITUTED POWDER. FIRST ACCESS TO DILUENT BOTTLE HAD A TINY PIECE OF MEMBRANE OBSERVED ON TOP OF PROTECTOR MEMBRANE. ADAPTER MEMBRANE ON BAG HAD A LOT OF SHINE AFTER DRUG WAS ADDED WITH THE INJECTOR THAT HAD BEEN ENGAGED 6 TIMES AT THIS POINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036710 BD PHASEAL OPTIMA PROTECTOR (P20-O MULTI) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2103406 00382905150654

    Patients

    Seq Age Sex Outcome Treatment
    1