BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 25X1 RB MCK

    MDR report key: 18270575 · Received December 5, 2023

    Report

    Report Number
    1213809-2023-01402
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    November 13, 2023
    Report Date
    February 21, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 9260311 ¿ FOLLOW UP MDR FOR DEVICE EVALUATION. DURING REVIEW OF THE PROCESSES, IT WAS DETERMINED PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. IT COULD BE POSSIBLE SOME SAMPLES ARE ESCAPES FROM THE INCIDENT THAT OCCURRED DURING PRODUCTION. CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN IMPLEMENTED. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE NEEDLE LUBRICANT APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    DEVICE PROBLEM CODE: A140901 - COMPLETE BLOCKAGE. PATIENT PROBLEM CODE: F26 ¿ NO HEALTH CONSEQUENCES OR IMPACT PR (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL#: UNKNOWN BATCH#: 2202913. IT WAS REPORTED BY CUSTOMER THAT THE PROBLEM IS THAT WE CANNOT INJECT VACCINE THROUGH THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE PROBLEM IS THAT WE CANNOT INJECT VACCINE THROUGH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049442 NEEDLE SFTYGLD 25X1 RB MCK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 2202913

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown