BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSEMBLY FIXTURE M12

    MDR report key: 11369517 · Received February 23, 2021

    Report

    Report Number
    3003152976-2021-00104
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 28, 2021
    Report Date
    May 7, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE PHOTO WHICH DISPLAYS A BROKEN VIAL ALONG WITH ONE ASSEMBLY FIXTURE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING A PROTECTOR TO A VIAL USING THE M12 ASSEMBLY FIXTURE, THE PROTECTOR WAS SUCCESSFULLY ATTACHED WITHOUT ISSUE. PRODUCT UNDERGOES 100% INSPECTION PRIOR TO RELEASE, INCLUDING VERIFYING THE FUNCTIONALITY OF THE VIAL HOLDERS. A REVIEW OF DEVICE RECORDS WAS PERFORMED FOR LOT 1910001, ALL PRODUCT WAS VERIFIED TO BE MANUFACTURED ACCORDING TO SPECIFICATION, NO ISSUES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED. BASED ON THE INVESTIGATION AND SAMPLE EVALUATION, 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 THE ASSEMBLY FIXTURE M12 WAS USED TO ATTACHED A PROTECTOR TO THE DARZALEX, CAUSING A CRACK ON THE BOTTOM OF THE VIAL THAT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "A PHARMACIST, WHO PREPARES ANTICANCER DRUG ON A DAILY BASIS, ATTACHED A PROTECTOR TO THE DARZALEX (400 MG) VIAL USING ASSEMBLY FIXTURE, AND THIS CAUSED A CRACK ON THE BOTTOM OF THE VIAL, RESULTING IN LEAKAGE."

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASSEMBLY FIXTURE M12 WAS USED TO ATTACHED A PROTECTOR TO THE DARZALEX, CAUSING A CRACK ON THE BOTTOM OF THE VIAL THAT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "A PHARMACIST, WHO PREPARES ANTICANCER DRUG ON A DAILY BASIS, ATTACHED A PROTECTOR TO THE DARZALEX (400 MG) VIAL USING ASSEMBLY FIXTURE, AND THIS CAUSED A CRACK ON THE BOTTOM OF THE VIAL, RESULTING IN LEAKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266476 ASSEMBLY FIXTURE M12 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1