BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 19913125 · Received August 5, 2024

    Report

    Report Number
    2243072-2024-00857
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NO SAMPLES OR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. 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. BASED ON THE QUALITY TEAM¿S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT CLOGGED NEEDLE CAN BE TRACED TO THE MANUFACTURING PROCESS. 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

    D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL # 305916 BATCH # UNKNOWN. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AHS MDIP REFERENCE NUMBER (ID): 44167. DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2024. SITE NAME/LOCATION: TWIN BROOKS PUBLIC HEALTH CENTRE. LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT. AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: NEEDLE WAS INSERTED, SYRINGE WOULD NOT COMPRESS. BD SAFETY GLIDE NEEDLE 25G 1 INCH LOT #REGX036B. CHILD REQUIRED SECOND POKE WITH NEW NEEDLE TO DELIVER VACCINE. QUERY BLOCKED NEEDLE? IMPACT OF INCIDENT: PATIENT RECEIVED VACCINATION, BUT REQUIRED AN ADDITIONAL POKE. WHO WAS AFFECTED? PATIENT. DEVICE INFORMATION: DEVICE NAME/DESCRIPTION: NEEDLE HYPODERMIC SAFETY 25GA X 1 IN. MANUFACTURER: BECTON DICKINSON CANADA INC. MANUFACTURER CODE/MODEL: 305916. SERIAL OR LOT NUMBER: (B)(6). DEVICE EXPIRY DATE (YYYY-MM-DD): UNKNOWN. SUPPLIER: (B)(4). SUPPLIER CATALOGUE NUMBER: 308-305916. WAS THE DEVICE RETAINED? NO. INVESTIGATION REQUEST. EXPECTED TYPE OF INVESTIGATION: LOT REVIEW. CLINICAL CONTACT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675432 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON REGX0368 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown