BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR LOCKING N40-O

    MDR report key: 12477872 · Received September 15, 2021

    Report

    Report Number
    3003152976-2021-00600
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 14, 2021
    Report Date
    September 27, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K201099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 AN INJECTOR LOCKING N40-O HAD THE INJECTOR LOOSE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE INJECTOR BECAME DISCONNECTED FROM THE CONNECTOR AND TUBING. " D.1. MEDICAL DEVICE BRAND NAME: NJECTOR LOCKING N40-O. D.4. MEDICAL DEVICE CATALOG #: 515056. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.4. PMA / 510(K)#: K201099. H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. 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, AND ADDITIONAL RETAINED SAMPLES CANNOT BE EVALUATED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INJECTOR LOCKING N40-O HAD THE INJECTOR LOOSE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE INJECTOR BECAME DISCONNECTED FROM THE CONNECTOR AND TUBING. "

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD PHASEAL INJECTOR N40-O HAD THE INJECTOR LOOSE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE INJECTOR BECAME DISCONNECTED FROM THE CONNECTOR AND TUBING. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373501 INJECTOR LOCKING N40-O INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1