BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM SS 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11527615 · Received March 19, 2021

    Report

    Report Number
    2243072-2021-00835
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 22, 2021
    Report Date
    April 28, 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

    INVESTIGATION SUMMARY ONE OE0420R SAMPLE FROM LOT 212004 WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION. A VISUAL INSPECTION CONFIRMED THE CUSTOMER¿S EXPERIENCE AS TWO AREAS OF EMBEDDED BLACK PARTICULATES WERE OBSERVED ON THE AIR VENT OF THE VIAL ACCESS DEVICE (APPENDICES 1 AND 2). THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER, YUKON MEDICAL LLC, FOR INVESTIGATION. THEIR ANALYSIS CONFIRMED THAT 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 212004 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST PRODUCTS MANUFACTURED AT THIS MANUFACTURING SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OEM SS 20MM VENTED VIAL ACCESS DEVICE HAD FOREIGN MATTER. THIS OCCURRED ON 160 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: OE0420R BATCH NO: 212004. IT WAS REPORTED THAT BLACK STAINS WERE FOUND ON THE FILTER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OEM SS 20MM VENTED VIAL ACCESS DEVICE HAD FOREIGN MATTER. THIS OCCURRED ON 160 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: OE0420R BATCH NO: 212004 IT WAS REPORTED THAT BLACK STAINS WERE FOUND ON THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422729 OEM SS 20MM VENTED VIAL ACCESS DEVICE I.V. FLUID TRANSFER SET LHI BECTON DICKINSON 212004

    Patients

    Seq Age Sex Outcome Treatment
    1