BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G

    MDR report key: 17671584 · Received September 1, 2023

    Report

    Report Number
    1213809-2023-00960
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 17, 2023
    Report Date
    September 29, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    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

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G THE NEEDLE WAS CLOGGED. THIS OCCURRED 34 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): YES. INCIDENT DETAILS: THIS IS A WEEKLY REPORT FROM AUG (B)(6). THIS IS FROM MULTIPLE NURSE AND I AM THE CDN DOING THE REPORT. LOT # 2007149 HAD 34 NEEDLES OF ISSUE. WE HAVE 2 SAMPLES RETAINED. THE ISSUE WAS UNABLE TO PLUNGE. IMPACT OF INCIDENT: NO PATIENT ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G THE NEEDLE WAS CLOGGED. THIS OCCURRED 34 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE. AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): YES. INCIDENT DETAILS: THIS IS A WEEKLY REPORT FROM AUG 9TH TO AUG 15TH. THIS IS FROM MULTIPLE NURSE AND I AM THE CDN DOING THE REPORT . LOT # 2007149 HAD 34 NEEDLES OF ISSUE. WE HAVE 2 SAMPLES RETAINED. THE ISSUE WAS UNABLE TO PLUNGE. IMPACT OF INCIDENT: NO PATIENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831108 BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2007149 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown