BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD CATHETER

    MDR report key: 11938044 · Received June 4, 2021

    Report

    Report Number
    2243072-2021-01591
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    November 26, 2020
    Report Date
    July 29, 2021
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS EVENT BUT WITHOUT A SAMPLE NO CORRECTIVE ACTIONS COULD BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. H3 OTHER TEXT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED BD CATHETER SEPARATED FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "22G CATHETER HAS COME DETACHED FROM THE LUBRICATED NEEDLE."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDRESS: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE LOT #: THE CUSTOMER REPORTED LOT# 0103235, HOWEVER IT DID NOT MATCH THE DESCRIPTION OF THE DEVICE. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD CATHETER SEPARATED FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "22G CATHETER HAS COME DETACHED FROM THE LUBRICATED NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833703 UNSPECIFIED BD CATHETER INTRAVASCULAR CATHETER FOZ SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1