BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK

    MDR report key: 20827401 · Received December 2, 2024

    Report

    Report Number
    1213809-2024-00908
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 5, 2024
    Report Date
    January 28, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059011
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON PHOTO EVALUATION, IT WAS OBSERVED THAT THE NEEDLE IS OUT OF THE NEEDLE HUB AND IN THE SAFETY MECHANISM. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4116104. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL #: 305901 BATCH#: 4116104. IT WAS REPORTED THAT THE BD SAFETY-LOK NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. WE HAVE RECEIVED THE BELOW PRODUCT PROBLEM REPORT. STEVENS REF#(B)(4) HAS BEEN ASSIGNED TO THIS ISSUE. UPON COMPLETION, PLEASE PROVIDE A QUALITY INVESTIGATION LETTER DETAILING YOUR FINDINGS. PLEASE ADVISE ON NEXT STEPS FOR QUALITY INVESTIGATION AND CUSTOMER RESOLUTION:PRODUCT PROBLEM REPORT PRODUCT INFORMATION PRODUCT CODE: 305901 PRODUCT DESCRIPTION: NEEDLE HYPO 25 X 5/8IN SAFETYGLIDE SUB Q BX/50 P42 LOT/SERIAL #: (B)(6) EXPIRY DATE: 2029-03-31. PROBLEM INFORMATION **CITE CUSTOMER COMPLAINT # (B)(4)** ADMINISTRATED FLU VACCINE IN RIGHT DELTOID MUSCLE, POST ADMIN UPON REMOVING NEEDLE, IT SEPARATED FROM THE ORANGE BUB & WAS DANGLING IN SAFETY DEVICE. DID NOT CAUSE HARM TO PATIENT, HOWEVER THERE WAS POTENTIAL THE NEEDLE COULD HAVE STAYED IN PATIENTS ARM. OCCURRENCES: 1 EAC REPORTER INFORMATION REPORTER NAME: XXXX REPORTER POSITION/DEPARTMENT: XX REPORTER PHONE: XXX REPORTER EMAIL: XXXX SITE INFORMATION XXXXX

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2473974 BD SAFETY-LOK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 4116104 30382903059011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown