BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM SS 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11397144 · Received March 2, 2021

    Report

    Report Number
    2243072-2021-00664
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    December 17, 2020
    Report Date
    April 21, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    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: AN OE0420R PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 202028. AS PART OF THE INVESTIGATION, THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE AFFECTED SAMPLE; ANALYSIS OF THE PHOTOGRAPH IDENTIFIED THAT THE GREEN PLASTIC OF THE VIAL ACCESS DEVICE APPEARED DARKER THAN THE USUAL COLOUR OF THE PRODUCT. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITHOUT THE AFFECTED SAMPLE, HOWEVER YUKON MEDICAL LLC CONFIRMED THAT AS THIS APPEARED TO BE AN ISOLATED OCCURRENCE IT IS LIKELY THAT THE THE DISCOLOURATION MAY HAVE OCCURRED ON START-UP OF THE MOULDING TOOL WHEN THE PROCESS PARAMETERS HAD NOT FULLY STABILISED. TYPICALLY THESE PRODUCTS ARE SEGREGATED AND DISPOSED OF, HOWEVER IN THIS INSTANCE IT APPEARS THAT THIS PRODUCT CONTINUED TO SUBSEQUENT ASSEMBLY STEPS DUE TO HUMAN ERROR. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 202028 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OEM SS 20MM VENTED VIAL ACCESS DEVICE EXPERIENCED DISCOLORATION OF DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE COLOR OF THE PRODUCT IS DARKER THAN THE REGULAR PRODUCT.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OEM SS 20MM VENTED VIAL ACCESS DEVICE EXPERIENCED DISCOLORATION OF DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE COLOR OF THE PRODUCT IS DARKER THAN THE REGULAR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299531 OEM SS 20MM VENTED VIAL ACCESS DEVICE VIAL ACCESS DEVICE LHI BECTON DICKINSON 202028

    Patients

    Seq Age Sex Outcome Treatment
    1