BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAP FOR INJECTOR MEMBRANE M50

    MDR report key: 11773886 · Received May 4, 2021

    Report

    Report Number
    3003152976-2021-00249
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 1, 2021
    Report Date
    June 10, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905154041
    PMA / PMN Number
    K092782
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1805103. D4: MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. D4: UDI # (B)(4). D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-04-27. G.5. PMA/510(K)#: K092782. H4: DEVICE MANUFACTURE DATE: 2018-05-11. H6: INVESTIGATION SUMMARY ONE INJECTOR CAP FROM LOT 1805103 WAS PROVIDED TO OUR QUALITY ENGINEER FOR EVALUATION. UPON INSPECTING THE PRODUCT, WHITE PARTICLES CAN BE OBSERVED ON THE SURFACE OF THE PRODUCT AS WELL AS INSIDE THE PACKAGING. THREE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. AFTER INSPECTING THE PRODUCT, NO PARTICLES WERE OBSERVED ON THE CAPS OR WITHIN THE PACKAGES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1805103, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. STERILIZATION TESTING WAS PERFORMED AND RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. BASED ON OUR INVESTIGATIONS THE PARTICLES WERE IDENTIFIED TO CONSIST OF TYVEK PAPER WHICH IS USED IN THE PACKAGING FOR THIS PRODUCT. THESE PARTICLES CAN ACCUMULATE IN THE ROLLERS FROM THE PACKAGING LINE AS THE PAPER PASSES THROUGH AND LIKELY FELL INTO THE BLISTER PACKAGE BEFORE THEY WERE SEALED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CAP FOR INJECTOR MEMBRANE M50 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT FOREIGN MATTER ON 515404. ACCORDING TO THE CUSTOMER'S REPORT, WHITE POWDER-LIKE FM ON 515404 WAS FOUND.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CAP FOR INJECTOR MEMBRANE M50 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT FOREIGN MATTER ON 515404. ACCORDING TO THE CUSTOMER'S REPORT, WHITE POWDER-LIKE FM ON 515404 WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668232 CAP FOR INJECTOR MEMBRANE M50 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1805103 00382905154041

    Patients

    Seq Age Sex Outcome Treatment
    1