BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK

    MDR report key: 18884754 · Received March 12, 2024

    Report

    Report Number
    1213809-2024-00159
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 8, 2024
    Report Date
    October 7, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059011
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO EXAMINE THE PHOTO FROM BATCH 3031742 REGARDING ITEM 305901. IT SHOWS A NEEDLE ASSEMBLY ASSEMBLED TO A SYRINGE. THE NEEDLE ASSEMBLY HAS THE SAFETY MECHANISM ACTIVATED. IT IS BROKEN IN TWO PIECES. NO OTHER DEFECT OR IMPERFECTION WAS OBSERVED. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3031742 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETY-LOK SAFETY MECHANISM BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOLLOWING ADMINISTRATION OF THE RSV IMMUNIZATION, I WAS ACTIVATING THE SAFETY ON A 25 G INJECTION NEEDLE AND THE SAFETY MALFUNCTIONED. IT DID NOT ACTIVATE ALL THE WAY, BENDING THE NEEDLE AND LEAVING THE TIP EXPOSED INSTEAD OF ACTIVATING FULLY." ADDITIONAL INFORMATION PROVIDED: 1. WAS THIS NOTED UPON OPENING THE PACKAGE? NO. 2. WAS THIS NOTED ON THE FIRST-TIME USE (IF NEEDLE USED MORE THAN ONCE): 1ST TIME USED. 3. PLEASE CONFIRM THE NUMBER OF OCCURRENCES: (B)(4). 4. KINDLY SHARE THE EXACT ADDRESS DETAILS TO SEND A RETURN SHIPPING LABEL: THE SAMPLE ISN¿T AVAILABLE; A PHOTO WAS INCLUDED IN THE REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029247 BD SAFETY-LOK SAFETYGLIDE NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 3031742 30382903059011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown