BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G

    MDR report key: 15352102 · Received September 2, 2022

    Report

    Report Number
    1213809-2022-00543
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 11, 2022
    Report Date
    October 6, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, (B)(6) WAS USED AS A PLACE HOLDER. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL: YES. D.9. RETURNED TO MANUFACTURER ON: 09-SEP-2022. H.6. INVESTIGATION SUMMARY: THIRTY-THREE SAMPLES FROM LOT 2024137, FOUR SAMPLES FROM LOT 2003405 AND THREE SAMPLES FROM UNKNOWN LOT WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. NO SAMPLES WERE RETURNED FROM LOT NUMBER 2007149. UPON VISUAL INSPECTION, NO DEFECTS OR ISSUES WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, EACH SAMPLE WAS CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ONE SAMPLE FROM UNKNOWN LOT DID NOT EXPEL THE SOLUTION DUE TO CLOGGED. THIS DEFECT COULD OCCUR IF THERE WAS A PROCESS VARIATION AT THE LUBRICATION STATION INDUCING THE SYMPTOM REPORTED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 2024137, 2003405 AND 2007149. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. A VERIFICATION OF THE NEEDLE LUBRICANT PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCTS WAS GOOD. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305916 . LOT # 2007149. BEEN HAVING PROBLEMS WITH BEING OCCLUDED AND UNABLE TO DRAW UP SOLUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305916 , LOT # 2007149. BEEN HAVING PROBLEMS WITH BEING OCCLUDED AND UNABLE TO DRAW UP SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384542 BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305916 2007149 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown