BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E

    MDR report key: 12303506 · Received August 10, 2021

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    Report

    Report Number
    2243072-2021-02040
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 7, 2021
    Report Date
    February 2, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    CAZ
    UDI-DI
    00382904060473
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. BASED ON THE PROVIDED PHOTO, THE REPORTED FAILURE WAS NOT CONFIRMED. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. AS THE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A DEVICE HISTORY REVIEW CANNOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E EXPERIENCED NEEDLE HUB HOLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS WEEK WE HAD TWO CONNECTORS IN YOUR EPIDURAL KIT THAT HAD A HOLE IN THE SIDE. OK BOTH INSTANCES WE WERE ABLE TO BREAK OPEN ANOTHER TYPE OF KIT AND USE THEIRS, BUT I WANTED TO LET YOU KNOW.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS HDQ US (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. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E EXPERIENCED NEEDLE HUB HOLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS WEEK WE HAD TWO CONNECTORS IN YOUR EPIDURAL KIT THAT HAD A HOLE IN THE SIDE. OK BOTH INSTANCES WE WERE ABLE TO BREAK OPEN ANOTHER TYPE OF KIT AND USE THEIRS, BUT I WANTED TO LET YOU KNOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199218 TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E ANESTHESIA CONDUCTION KIT CAZ BECTON DICKINSON 406047 UNKNOWN 00382904060473

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown