BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE VIAL ACCESS DEVICE VENTED WITH SS

    MDR report key: 11418413 · Received March 4, 2021

    Report

    Report Number
    2243072-2021-00705
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 8, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-03-24 H6: INVESTIGATION SUMMARY THREE HUNDRED AND FORTY-TWO MV0400-0006 SAMPLES FROM LOT 202019 WERE RECEIVED IN SEALED PACKAGING FOR INVESTIGATION; THE REPORTED COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION. HOWEVER AS PART OF THE CUSTOMER FEEDBACK THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE AFFECTED SAMPLE, ANALYSIS OF THE PHOTOGRAPH CONFIRMED THAT THE SMARTSITE HAD SEPARATED FROM THE VIAL ACCESS DEVICE. SIXTY SAMPLES WERE SENT TO BD PRODUCT TEST LABORATORY TO UNDERGO TENSILE TESTING IN ACCORDANCE WITH THE REQUIREMENTS OF BS: EN: ISO 8536-9: INFUSION EQUIPMENT FOR MEDICAL USE. FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT. THE PRODUCT MET AND EXCEEDED THE TENSILE REQUIREMENTS OF THE STANDARD. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 202019 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. ALTHOUGH THE SEPARATION COULD BE CONFIRMED FROM ANALYSIS OF THE PHOTOGRAPHS, THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SINGLE VIAL ACCESS DEVICE VENTED WITH SS EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PUNCHES (TRANSFER SPIKE(S) - VENTED) ARE PLUGGED. THE PART OF THE PUNCH THAT SHOULD BE GLUED IS LOOSE. WHEN DID THE INCIDENT OCCUR? -UNKNOWN.

    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. 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 SINGLE VIAL ACCESS DEVICE VENTED WITH SS EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PUNCHES (TRANSFER SPIKE(S) - VENTED) ARE PLUGGED. THE PART OF THE PUNCH THAT SHOULD BE GLUED IS LOOSE. WHEN DID THE INCIDENT OCCUR? UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311799 SINGLE VIAL ACCESS DEVICE VENTED WITH SS VIAL ACCESS DEVICE LHI BECTON DICKINSON 202019

    Patients

    Seq Age Sex Outcome Treatment
    1