BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK

    MDR report key: 18207783 · Received November 26, 2023

    Report

    Report Number
    1213809-2023-01339
    Event Type
    Malfunction
    Date Received
    November 26, 2023
    Date of Event
    October 25, 2023
    Report Date
    December 5, 2023
    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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4)- FOLLOW UP MDR FOR DEVICE EVALUATION. NO SAMPLES OR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, 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. 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. MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETY-LOK NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY CUSTOMER THAT CAREGIVER WAS DRAWING UP VACCINE WITH BLUNT TIP NEEDLE, THEN SWITCHED TO BD 5/8" SAFETYGLIDE NEEDLE LOT# 3241135 EXP# 7/31/2028. SHE TRIED TO CLEAR THE AIR BUBBLE IN THE SYRINGE AND DISCOVERED THAT THERE WAS A VAPOR LOCK IN THE SYRINGE AND THAT THE NEEDLE WAS NOT BORED OUT. UNFORTUNATELY NO SAMPLES OR PHOTOS WERE SAVED. THIS IS THE SECOND ISSUE MATCHING THIS DESCRIPTION."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499997 BD SAFETY-LOK SAFETYGLIDE NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 3241135 30382903059011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown