BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 25X1 RB

    MDR report key: 18284036 · Received December 7, 2023

    Report

    Report Number
    1213809-2023-01417
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 15, 2023
    Report Date
    February 10, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PROBLEM CODE: A040102 - LOSS OF OR FAILURE TO BOND\ PATIENT PROBLEM CODE: F26 ¿ NO HEALTH CONSEQUENCES OR IMPACT (B)(6). INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4).- FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED THE NEEDLE CAME OUT OF THE PLASTIC CONNECTOR AND STUCK IN THE PATIENT¿S ARM. TO AID IN THE INVESTIGATION, ONE HUNDRED TWENTY-FIVE SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305916, LOT 3201119. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 3201119 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF NEEDLES USED IN THE MANUFACTURING OF THIS BATCH. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THESE BATCHES. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. 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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    MATERIAL#: 305916 BATCH#: UNKNOWN (BATCH NUMBER PROVIDED BY CUSTOMER: 320119) IT WAS REPORTED BY CUSTOMER THAT A PATIENT INCIDENT REPORT WAS FILED WITH THEIR RISK MANAGEMENT DEPARTMENT ON THE BD 305916 ¿ 25G X 1 SAFETY GLIDE INJECTION NEEDLE ¿ LOT #320119. VERBATIM: A PATIENT INCIDENT REPORT WAS FILED WITH OUR RISK MANAGEMENT DEPARTMENT ON THE BD 305916 ¿ 25G X 1 SAFETY GLIDE INJECTION NEEDLE ¿ LOT #320119. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ADDITIONAL INFORMATION RECEIVED ON (B)(6). 2023 1) WHAT IS THE ISSUE REPORTED. IT WAS JUST MENTIONED IN THE COMMUNICATION A PATIENT INCIDENT REPORT WAS FILED WITH OUR RISK MANAGEMENT DEPARTMENT. BUT FOR WHAT THE REPORT WAS FILED? WHAT WAS THE FAILURE REPORTED WITH THE BD PRODUCT? THE NEEDLE CAME OUT OF THE PLASTIC CONNECTOR AND STUCK IN THE PATIENT¿S ARM. THE MA WAS ABLE TO GET IT OUT, BUT THE ENTIRE UNIT WAS DISPOSED IN THE SHARPS CONTAINER. ONCE THIS HAPPENED, WE PULLED ALL THE SAME LOT NUMBER FROM ALL OUR LOCATIONS. 2) WHAT WAS THE PATIENT IMPACT? NO HARM TO THE PATIENT. 3) PLEASE CONFIRM LOT NUMBER. THE LOT NUMBER PROVIDED 320119 WAS NOT FOUND IN OUR RECORDS THE REF #(B)(4). LOT #3201119 PICTURE ATTACHED. 4) IS THE SAMPLE AVAILABLE TO SEND BACK FOR EVALUATION? IF YES, PLEASE PROVIDE SHIPPING ADDRESS FOR SENDING A RETURN LABEL FROM US RCC. THE DEFECTIVE UNIT THAT WAS USED ON THE PATIENT IS NOT AVAILABLE, BUT I DO HAVE ITEMS FROM THE SAME BOX/LOT NUMBER IF NEEDED. IF YOU NEED THESE SENT BACK, THE ADDRESS IS: (B)(6).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877709 NEEDLE SFTYGLD 25X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3201119 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown