BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM SS 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11417694 · Received March 4, 2021

    Report

    Report Number
    2243072-2021-00700
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    December 17, 2020
    Report Date
    March 29, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    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

    H.6. INVESTIGATION: AN OE0420R PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER, THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 202036. AS PART OF THE INVESTIGATION, THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE AFFECTED SAMPLE; ANALYSIS OF THE PHOTOGRAPH IDENTIFIED BLACK CONTAMINATION ON THE FILTER WHICH APPEARS TO BE EMBEDDED ONTO THE PLASTIC MATERIAL. IN THIS INSTANCE WITHOUT THE SAMPLE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, HOWEVER ANALYSIS PERFORMED BY YUKON MEDICAL LLC CONFIRMED THAT THE CONTAMINANT APPEARS TO BE EMBEDDED INTO THE PLASTIC OF THE AIR VENT FILTER. IN THIS INSTANCE THE CONTAMINANT IS LIKELY TO HAVE BEEN BURNT GRANULES FROM THE RAW MATERIAL THAT HAVE BEEN EMBEDDED INTO THE PLASTIC OF THE AIR VENT FILTER DURING THE INJECTION MOULDING PROCESS. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 202036 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 H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OEM SS 20MM VENTED VIAL ACCESS DEVICE EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK STAINS WERE FOUND ON THE FILTER 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OEM SS 20MM VENTED VIAL ACCESS DEVICE EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLACK STAINS WERE FOUND ON THE FILTER PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311749 OEM SS 20MM VENTED VIAL ACCESS DEVICE VIAL ACCESS DEVICE FMI BECTON DICKINSON 202036

    Patients

    Seq Age Sex Outcome Treatment
    1