BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 19495388 · Received June 9, 2024

    Report

    Report Number
    1213809-2024-00359
    Event Type
    Malfunction
    Date Received
    June 9, 2024
    Date of Event
    April 26, 2024
    Report Date
    June 20, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479262598
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. 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.

    Description of Event or Problem · 0

    MATERIALS#: (B)(4) , BATCH#: 2202914. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VACCINE WOULD NOT PUSH THROUGH THE NEEDLES." PRODUCT DETAILS - NEEDLE, SFTY 192-N251S PREVENTSG ORG 25GX1" LOT - 2202914. ADDITIONAL INFORMATION PROVIDED: ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY? IF UNKNOWN, CAN STATE UNKNOWN. THE DATE THE FAULTY NEEDLES WERE DISCOVERED WAS (B)(6) 2024. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? THERE WERE NO HEALTH CONSEQUENCES TO ANY PATIENTS. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? NO ADVERSE EVENTS OR SERIOUS INJURIES OCCURRED.

    Description of Event or Problem · 0

    MATERIALS#: 306616, BATCH#: 2202914. IT WAS REPORTED BY THE CUSTOMER THAT THE VACCINE WOULD NOT PUSH THROUGH THE NEEDLES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. VACCINE WOULD NOT PUSH THROUGH THE NEEDLES. PRODUCT DETAILS - NEEDLE, SFTY 192-N251S PREVENTSG ORG 25GX1". LOT - 2202914.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2320062 BD SAFETYGLIDE SAFETYGLIDE NEEDLES FMI BECTON DICKINSON MEDICAL SYSTEMS 2202914 10612479262598

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown