BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 19422809 · Received May 30, 2024

    Report

    Report Number
    1213809-2024-00328
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 16, 2024
    Report Date
    July 11, 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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EIGHTEEN SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. EIGHT SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW, AND 10 WERE CLOGGED. THE DEFECT WAS CONFIRMED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 2024137. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    MATERIALS#: 305916, BATCH#: 2024137. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE HAD INSTANCES WHEN TRYING TO INJECT VACCINES INTO A PATIENT THAT THE SAFETYGLIDE 305916 NEEDLE FAILED TO ALLOW THE SOLUTION TO BE INJECTED INTO THE PATIENT AND THEY HAD TO REPLACE THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CUSTOMER REPORTS THAT OVER THE LAST 3 WEEKS THEY HAVE HAD INSTANCES WHEN TRYING TO INJECT VACCINES INTO A PATIENT THAT THE SAFETYGLIDE 305916 NEEDLE FAILED TO ALLOW THE SOLUTION TO BE INJECTED INTO THE PATIENT AND THEY HAD TO REPLACE THE NEEDLE. IT WAS REPORTED THAT THIS HAS HAPPENED TO SEVERAL DIFFERENT USERS. THE LATEST TOOK PLACE TODAY AND THE CUSTOMER REPORTED USING 6 NEEDLES UNSUCCESSFULLY. THE LOT NUMBER FOR TODAYS NEEDLES IS 2024137.

    Description of Event or Problem · 0

    MATERIALS#: 305916 BATCH#: 2024137 IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE HAD INSTANCES WHEN TRYING TO INJECT VACCINES INTO A PATIENT THAT THE SAFETYGLIDE 305916 NEEDLE FAILED TO ALLOW THE SOLUTION TO BE INJECTED INTO THE PATIENT AND THEY HAD TO REPLACE THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CUSTOMER REPORTS THAT OVER THE LAST 3 WEEKS THEY HAVE HAD INSTANCES WHEN TRYING TO INJECT VACCINES INTO A PATIENT THAT THE SAFETYGLIDE 305916 NEEDLE FAILED TO ALLOW THE SOLUTION TO BE INJECTED INTO THE PATIENT AND THEY HAD TO REPLACE THE NEEDLE. IT WAS REPORTED THAT THIS HAS HAPPENED TO SEVERAL DIFFERENT USERS. THE LATEST TOOK PLACE TODAY AND THE CUSTOMER REPORTED USING 6 NEEDLES UNSUCCESSFULLY. THE LOT NUMBER FOR TODAYS NEEDLES IS 2024137. ADDITIONAL INFORMATION PROVIDED: 1. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY? IF UNKNOWN, CAN STATE UNKNOWN. A. THE LATEST DATE IS NOW 5/16. 2. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? A. NO PATIENT HARM WAS EXPERIENCED, THE CLINICIAN CHECKED THE PATENCY OF THE NEEDLE PRIOR TO TRY TO INJECT. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? A. NOT THIS TIME. BUT A LOT OF NEEDLES HAVE BEEN WASTED. THEY HAVE 10 SAMPLES THAT CAN BE RETURNED FOR ANALYSIS 4. ANY PHYSICAL SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION OF AFFECTED PRODUCT? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? A. YES, THE CLINICIAN HAS SAVED 10 SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151575 BD SAFETYGLIDE SAFETYGLIDE NEEDLES FMI BECTON DICKINSON MEDICAL SYSTEMS 2024137 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown