BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAG ACCESS DEVICE W/CKV

    MDR report key: 11009539 · Received December 15, 2020

    Report

    Report Number
    2243072-2020-02059
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 18, 2020
    Report Date
    January 5, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    37613203011663
    PMA / PMN Number
    K970485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A BAG ACCESS DEVICE W/CKV HAD DAMAGED OR DEFECTIVE TUBING DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS AN ISSUE WITH THE SMARTSITE BAG ACCESS DEVICE. ONCE THE IV BAG IS SPIKED WITH THE SMARTSITE BAG ACCESS DEVICE, THE NURSE CANNOT PULL BACK FLUID FROM THE BAG." VERBATIM: CAN WE PLEASE CONNECT WITH CHAD AT LA COUNTY TO RESOLVE THE MATTER WITH ITEM #2309E." D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 12/28/2020 D.4. MEDICAL DEVICE LOT #: 20076260 D.4. MEDICAL DEVICE EXPIRATION DATE: 7/25/2023 H.4. DEVICE MANUFACTURE DATE: 7/9/2020 H.6. INVESTIGATION: TWO SAMPLES WERE RETURNED FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE SAMPLES, IT WAS OBSERVED THAT THE CHECK VALVE WAS ASSEMBLED IN THE INCORRECT ORIENTATION FOR ONE OF THE SAMPLES. NO OTHER DEFECTS WERE OBSERVED. THE TWO SAMPLES WERE THEN PRIMED. THE MISASSEMBLED SAMPLE COULD NOT BE PRIMED AND COULD NOT DRAW LIQUID; THE CUSTOMER COMPLAINT WAS VERIFIED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2309E LOT NUMBER 20076260 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF COMPONENT DAMAGE WITH LOT #20076260 REGARDING ITEM #2309E. THE ROOT CAUSE OF THIS FAILURE WAS IDENTIFIED AS AN ERROR DURING THE ASSEMBLY PROCESS. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BAG ACCESS DEVICE W/CKV HAD DAMAGED OR DEFECTIVE TUBING DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS AN ISSUE WITH THE SMARTSITE BAG ACCESS DEVICE. ONCE THE IV BAG IS SPIKED WITH THE SMARTSITE BAG ACCESS DEVICE, THE NURSE CANNOT PULL BACK FLUID FROM THE BAG." VERBATIM: CAN WE PLEASE CONNECT WITH CHAD AT LA COUNTY TO RESOLVE THE MATTER WITH ITEM #2309E."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BAG ACCESS DEVICE W/CKV HAD DAMAGED OR DEFECTIVE TUBING DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS AN ISSUE WITH THE SMARTSITE BAG ACCESS DEVICE. VERBATIM: CAN WE PLEASE CONNECT WITH (B)(6) TO RESOLVE THE MATTER WITH ITEM #2309E."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478667 BAG ACCESS DEVICE W/CKV INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 2309E 20076260 37613203011663

    Patients

    Seq Age Sex Outcome Treatment
    1