BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ ASSEMBLY FIXTURE M12

    MDR report key: 14739364 · Received June 17, 2022

    Report

    Report Number
    3003152976-2022-00278
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 20, 2022
    Report Date
    June 29, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE PHOTO SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE VISUAL INSPECTION, THE PHOTO DISPLAYS ONE PROTECTOR CONNECTED TO A VIAL WITH THE BOTTOM OF THE VIAL BROKEN. NO DEFECTS CAN BE OBSERVED IN THE PHOTO RELATED TO THE PROTECTOR AND NO SAMPLE OR PHOTO OF THE ASSEMBLY FIXTURE WAS AVAILABLE. PRODUCT UNDERGOES 100% INSPECTION PRIOR TO RELEASE, INCLUDING VERIFYING THE FUNCTIONALITY OF THE VIAL HOLDERS. AS THE ASSEMBLY FIXTURE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR PROTECTOR LOT 1902101, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO THE ASSEMBLY FIXTURE OR OUR PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD PHASEAL¿ ASSEMBLY FIXTURES M12 HAD ISSUES WITH THEIR VIALS CRACKING AND BREAKING OFF DURING RITUXAN PREPARATION WHEN USING THE PHASEAL PROTECTORS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "VIAL CRACK. THIS IS A REPORT ABOUT VIAL BREAKAGE WITH THE USE OF PROTECTOR. THE CUSTOMER REPORTED AS FOLLOWS: DURING PREPARATION OF RITUXAN USING ASSEMBLY FIXTURE, THE VIAL BROKE OFF; THIS OCCURRED IN THREE CASES WHERE THREE DIFFERENT HCPS HANDLED THE PRODUCTS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD PHASEAL¿ ASSEMBLY FIXTURES M12 HAD ISSUES WITH THEIR VIALS CRACKING AND BREAKING OFF DURING RITUXAN PREPARATION WHEN USING THE PHASEAL PROTECTORS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "VIAL CRACK. THIS IS A REPORT ABOUT VIAL BREAKAGE WITH THE USE OF PROTECTOR. THE CUSTOMER REPORTED AS FOLLOWS: DURING PREPARATION OF RITUXAN USING ASSEMBLY FIXTURE, THE VIAL BROKE OFF; THIS OCCURRED IN THREE CASES WHERE THREE DIFFERENT HCPS HANDLED THE PRODUCTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311425 BD PHASEAL¿ ASSEMBLY FIXTURE M12 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown BD PHASEAL¿ PROTECTOR (P50 MULTI).