BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 18592910 · Received January 28, 2024

    Report

    Report Number
    1213809-2024-00035
    Event Type
    Malfunction
    Date Received
    January 28, 2024
    Date of Event
    January 10, 2024
    Report Date
    February 21, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) ¿ FOLLOW UP MDR FOR DEVICE EVALUATION: IT WAS REPORTED SEVERAL NEEDLES FROM THE SAME LOT ARE NOT EXPELLING THE VACCINE INTO THE TISSUE. TO AID IN THE INVESTIGATION, SIX HUNDRED EIGHTY-TWO SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. EIGHTY SAMPLES WERE RANDOMLY SELECTED FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH OF THE EIGHTY SAMPLES WERE THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. SEVENTY-SEVEN SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. THREE SAMPLES DID NOT EXPEL THE SOLUTION; THESE THREE NEEDLES ARE CLOGGED. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN INDUCE CLOGGED NEEDLES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305916, LOT 2024137. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 2024137 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. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED IN THE MANUFACTURING PROCESS TO ENSURE THE NEEDLE LUBRICATION IS APPLIED APPROPRIATELY. 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 RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS 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

    IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "SEVERAL NEEDLES FROM EACH BOX OF THE SAME LOT ARE NOT EXPIRING VACCINE INTO THE TISSUE. THE PLUNGER STOPS AND DOES NOT MOVE ANY FURTHER CAUSING A REPEATED STICK." VERBATIM: PO#: (B)(6). ITEM#: (B)(4). CAT#305916. LOT#2924137. QUANTITY: 14BX. COMMENTS: SEVERAL NEEDLES FROM EACH BOX OF THE SAME LOT ARE NOT EXPIRING VACCINE INTO THE TISSUE. THE PLUNGER STOPS AND DOES NOT MOVE ANY FURTHER CAUSING A REPEATED STICK. CUSTOMER: (B)(6). (LOT#2024137- SEVERAL).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1393454 BD SAFETYGLIDE SAFETYGLIDE NEEDLES FMI BECTON DICKINSON MEDICAL SYSTEMS 2024137 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown