BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHENA 20GX1.00IN STRAIGHT BC

    MDR report key: 9908153 · Received March 31, 2020

    Report

    Report Number
    8041187-2020-00188
    Event Type
    Malfunction
    Date Received
    March 31, 2020
    Date of Event
    March 11, 2020
    Report Date
    May 11, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903868032
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CONNECTION ISSUE OCCURRED WITH A CATHENA 20GX1.00IN STRAIGHT BC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DIFFICULTY IN CONNECTING THE 3-WAY TAP INFUSION SET AND THE BLEEDING SET AND UNTIMELY DISCONNECTION OF THE LINES. THE INFUSION LINE DISCONNECTS AFTER A FEW HOURS. THE BLEEDING TUBING: IMPOSSIBLE TO PERFORM THE BLEEDING, WERE FORCED TO PERFORM THE BLEEDING FROM A SYRINGE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9050983. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2019-02-19. MEDICAL DEVICE LOT #: 9021623. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. DEVICE MANUFACTURE DATE: 2019-01-21. 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 A CONNECTION ISSUE OCCURRED WITH A CATHENA 20GX1.00IN STRAIGHT BC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DIFFICULTY IN CONNECTING THE 3-WAY TAP INFUSION SET AND THE BLEEDING SET AND UNTIMELY DISCONNECTION OF THE LINES. THE INFUSION LINE DISCONNECTS AFTER A FEW HOURS. THE BLEEDING TUBING: IMPOSSIBLE TO PERFORM THE BLEEDING, WERE FORCED TO PERFORM THE BLEEDING FROM A SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365477 CATHENA 20GX1.00IN STRAIGHT BC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 386803 SEE. H.10 00382903868032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other