BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 23X1 RB

    MDR report key: 18184915 · Received November 21, 2023

    Report

    Report Number
    1213809-2023-01318
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 24, 2023
    Report Date
    March 5, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903059028
    PMA / PMN Number
    K951254
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) : INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT. DEVICE PROBLEM CODE: A140901 - COMPLETE BLOCKAGE. TWO BATCH NUMBERS PROVIDED: BATCH NUMBER 3152813 MANUFACTURED ON 2023-06-01 AND BATCH NUMBER 2018060, MANUFACTURED ON 2022-01-18.

    Additional Manufacturer Narrative · 0

    PR 9151862 ¿ FOLLOW UP MDR FOR DEVICE EVALUATION 29 SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE SAMPLES CAME IN SEALED PACKAGING BLISTERS. A VISUAL INSPECTION WAS PERFORMED. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3152813. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. DURING REVIEW OF THE PROCESS, PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. 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. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED WAS NOT CONFIRMED. 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.

    Description of Event or Problem · 0

    MAT# 305902, LOT# 3152813, 2018060. IT WAS REPORTED BY THE CUSTOMER THAT WHILE PRIMING THE NEEDLE RESISTANCE WAS MET, UNABLE TO PUSH AIR THOUGH NEEDLE. DISCOVERED DURING PRIMING - NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925561 NEEDLE SFTYGLD 23X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MULTIPLE: SEE H10 30382903059028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown