BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 25X1 RB

    MDR report key: 18334634 · Received December 15, 2023

    Report

    Report Number
    1213809-2023-01454
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 14, 2023
    Report Date
    December 16, 2023
    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

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(6) FOLLOW UP MDR FOR DEVICE EVALUATION. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. 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. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    MATERIAL#: 305916. BATCH# 2287687. IT WAS REPORTED BY CUSTOMER THAT I WAS DOING ROUTINE GRADE 9 VACCINATIONS ON A STUDENT. THE PREFILLED BOOSTRIX SYRINGES DO NOT HAVE A LUER LOCK TIP. I HAD JUST OPENED A NEW BOX OF NEEDLES (LOT # 2287687). I ATTACHED THE TIP AND PREPARED THE STUDENT FOR VACCINATING. AFTER I STUCK THE PATIENT WITH THE NEEDLE, WHEN I DEPRESSED THE END OF THE SYRINGE THE NEEDLE POPPED OFF SPRAYING VACCINE. WONDERING IF THE NEEDLE WAS BLOCKED, EXCESS SILICONE DUE TO HISTORY OF SAME. NO IMAGES, ISSUE NOT VISIBLE. REPORTING FOR TRACKING AND TRENDING PURPOSES. IMPACT OF INCIDENT: THE STUDENT REQUIRED A SECOND NEEDLE TO GET ADEQUATE PROTECTION FOR DTAP DUE TO THE INEFFECTIVE DOSE. WHO WAS AFFECTED? PATIENT VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AHS MDIP REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT (YYYY-MM-DD): 2023-11-14. SITE NAME/LOCATION: (B)(6). LEVEL OF HARM: NO APPARENT HARM - REACHED PATIENT/PERSON, INCONVENIENT. AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: I WAS DOING ROUTINE GRADE 9 VACCINATIONS ON A STUDENT. THE PREFILLED BOOSTRIX SYRINGES DO NOT HAVE A LUER LOCK TIP. I HAD JUST OPENED A NEW BOX OF NEEDLES (LOT # 2287687). I ATTACHED THE TIP AND PREPARED THE STUDENT FOR VACCINATING. AFTER I STUCK THE PATIENT WITH THE NEEDLE, WHEN I DEPRESSED THE END OF THE SYRINGE THE NEEDLE POPPED OFF SPRAYING VACCINE. WONDERING IF THE NEEDLE WAS BLOCKED, EXCESS SILICONE DUE TO HISTORY OF SAME. NO IMAGES, ISSUE NOT VISIBLE. REPORTING FOR TRACKING AND TRENDING PURPOSES. IMPACT OF INCIDENT: THE STUDENT REQUIRED A SECOND NEEDLE TO GET ADEQUATE PROTECTION FOR DTAP DUE TO THE INEFFECTIVE DOSE. 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: MEDLINE CANADA CORPORATION. SUPPLIER CATALOGUE NUMBER: 308-305916. WAS THE DEVICE RETAINED? NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297878 NEEDLE SFTYGLD 25X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 2287687 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown