BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1-1/2 RB

    MDR report key: 21191342 · Received January 20, 2025

    Report

    Report Number
    1911916-2025-00024
    Event Type
    Malfunction
    Date Received
    January 20, 2025
    Date of Event
    January 6, 2025
    Report Date
    February 18, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    B3 UPDATED. THE DATE RECEIVED BY MANUFACTURER WAS UPDATED AND ENTERED INTO THE DATE OF EVENT FIELD. THE ACTUAL DATE OF EVENT IS UNKNOWN. DEVICE EVALUATION: IT WAS REPORTED THERE ARE ISSUES WITH THE NEEDLE AFTER OMNIPAQUE IS INJECTED. TO AID IN THE INVESTIGATION, TWO SAMPLES IN SEALED PACKAGING BLISTERS AND ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS ASSEMBLED TO A SYRINGE WITH SALINE SOLUTION; BOTH SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. THE PHOTO PROVIDED SHOWS THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305127, LOT 3209585. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. 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

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL # 305127. BATCH # 3209585. "IN THE PAST WE COULD USE ONE NEEDLE AND SWITCH THE SYRINGE OUT WITH THE THREE INJECTIONS: LIDOCAINE, OMNIPAQUE 300, AND THE STEROID. IT IS BEING REPORTED THAT THEY ARE HAVING ISSUES WITH THE NEEDLE AFTER THE OMNIPAQUE IS INJECTED.". CUSTOMER RESPONSE RECEIVED ON 06-JAN-2025. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? WHAT KIND OF ISSUE THEY WERE FACED? DIFFICULTY ADMINISTERING STEROID THROUGH 25G BD 1.5¿ NEEDLES FOR STEROID JOINT INJECTIONS. I HAVE BEEN USING THESE NEEDLES FOR GREATER THAN ONE YEAR FOR JOINT INJECTIONS. RECENTLY IN THE LAST MONTH, I WILL GET THE NEEDLE IN PLACE, INJECT OMNIPAQUE 300 THROUGH THE NEEDLE TO CONFIRM CORRECT NEEDLE PLACEMENT AND THEN GO TO INJECT THE STEROID AND WILL BE UNABLE TO PUSH ANYTHING THROUGH THE NEEDLE. I HAVE BEEN DOING THE SAME TECHNIQUE WITH THE SAME EQUIPMENT AND THE SAME MEDICATIONS FOR GREATER THAN ONE YEAR. IT WAS JUST OVER THE PAST MONTH OR SO THAT THIS PROBLEM HAS ARISEN. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? APPROXIMATELY FROM THE END NOVEMBER 2024 TO PRESENT DAY. PLEASE SHARE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE 3209585. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THIS RESULTS IN A LARGER NEEDLE BEING USED THAN NECESSARY AND A SECOND NEEDLE PUNCTURE TO THE JOINT. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? YES. (B)(6). PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE. N/A. THE LOT NUMBER [3209585] WAS NOT MATCHING FOR MATERIAL NUMBER [405161]. COULD YOU PLEASE CHECK AND RECONFIRM THE LOT NUMBER?

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644970 NEEDLE 25X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3209585 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown