BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 18307412 · Received December 11, 2023

    Report

    Report Number
    1213809-2023-01441
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    November 3, 2023
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBER INCLUDES 2040095 AND OTHER EXPIRATION DATE INCLUDES 2027-01-31. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2022-02-09.

    Additional Manufacturer Narrative · 0

    PR 9300487 ¿ 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE PULLED OUT OF HUB, THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IM IMMUNIZATION INJECTION OF PREFILLED SYRINGE ATTACHED TO 1" NEEDLE. NEEDLE PRIMED PRIOR TO INJECTION. UPON INJECTION OF VACCINE, NEEDLE SEPARATED AT HUB AND VACCINE SPRAYED OUT DUE TO RESISTANCE IN NEEDLE UPON INJECTION." IMPACT OF INCIDENT: CHILD REQUIRED REPEAT IM INJECTION. WHO WAS AFFECTED? PATIENT. FREQUENCY OF PROBLEM: FIRST TIME. PROCEDURE: IM INJECTION. DEVICE NAME/DESCRIPTION: NEEDLE HYPODERMIC SAFETY 25GA X 1 IN. MANUFACTURER: BECTON DICKINSON CANADA INC. MANUFACTURER CODE/MODEL: 305916. SERIAL OR LOT NUMBER: LOT 2040124 EXP: 2027-01-31 LOT 2040095 EXP: 2027-01-31 LOT REGX0370 EXP: 2027-09-30. 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
    1304230 BD SAFETYGLIDE SAFETYGLIDE NEEDLES FMI BECTON DICKINSON MEDICAL SYSTEMS 2040124 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown