BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 23X1-1/2 RB

    MDR report key: 20825032 · Received December 2, 2024

    Report

    Report Number
    1911916-2024-00862
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 25, 2024
    Report Date
    December 19, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051947
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THE NEEDLES WOULD NOT PUSH MEDICATION OUT. TO AID IN THE INVESTIGATION, SEVEN SAMPLES IN SEALED PACKAGING BLISTERS, ONE PHOTO AND ONE VIDEO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN ASSEMBLED TO A SYRINGE WITH SALINE SOLUTION. ALL THE SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. THE VIDEO SHOWS A NEEDLE ASSEMBLED TO A SYRINGE WITH A HUMAN HAND PUSH THE PLUNGER ROD IN. NO SOLUTION IS OBSERVED COMING OUT OF THE NEEDLE TIP. THE PHOTO PROVIDED SHOWS A PACKAGING BLISTER TOP WEB. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305194, LOT 3347792. 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. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL#:305194, BATCH#:3347792. WE EXPERIENCED ANOTHER ONE OF OUR XXXXXXXXXXXXXXX LOCATION HAVING THE SAME ISSUE WITH THE SAME PRODUCT. ARE YOU ABLE TO DO THE SAME PROCESS WE DID WITH THE OTHER LOCATIONS WE JUST DID TO THIS ONE BELOW THAT JUST EXPERIENCED THIS ISSUE. WE HAVE HAD ISSUES WITH THE BD NEEDLES NOT PUSHING MEDICATION OUT. MY MEDICAL ASSISTANTS HAVE SAID THERE HAVE BEEN ABOUT 3-5 A DAY WHERE THEY WENT TO INJECT THE MEDICATION AND NOTHING WAS PUSHING OUT. THE LOT NUMBER IS 3347792. I ATTACHED A PICTURE AND VIDEO OF THE INSTANCE HAPPENING. THIS IS CAUSING A PATIENT TO HAVE TO BE STUCK TWICE BECAUSE OF THIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333285 NEEDLE 23X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3347792 30382903051947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown