BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM SS 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11397184 · Received March 2, 2021

    Report

    Report Number
    2243072-2021-00670
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Date of Event
    December 24, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES. RETURNED TO MANUFACTURER ON: 2021-02-02. INVESTIGATION SUMMARY ONE OE0420R SAMPLE FROM LOT 202047 WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION. A VISUAL INSPECTION CONFIRMED THE CUSTOMER EXPERIENCE AS TWO OF THE RETAINING TABS OF THE VIAL ACCESS DEVICE (VAD) WERE FOUND TO HAVE BEEN SNAPPED OFF. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER, YUKON MEDICAL LLC, FOR INVESTIGATION. ANALYSIS OF THE MANUFACTURING PROCESS DID NOT IDENTIFY A DEFINITIVE ROOT CAUSE FOR THE OBSERVED DAMAGE; HOWEVER IT IS POSSIBLE THAT THE DAMAGE OCCURRED AS A RESULT OF STRESS TO THE COMPONENT DURING BULK TRANSPORTATION, OR DAMAGE SUSTAINED DURING THE MANUFACTURING PROCESS OF THE COMPONENT. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 202047 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OEM SS 20MM VENTED VIAL ACCESS DEVICE EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECT ON THE HOUSING PART.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OEM SS 20MM VENTED VIAL ACCESS DEVICE EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECT ON THE HOUSING PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299585 OEM SS 20MM VENTED VIAL ACCESS DEVICE VIAL ACCESS DEVICE LHI BECTON DICKINSON 202047

    Patients

    Seq Age Sex Outcome Treatment
    1