BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA BLUNT PLASTIC

    MDR report key: 20788802 · Received November 26, 2024

    Report

    Report Number
    1911916-2024-00850
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 12, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K974363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP. IT WAS REPORTED THERE WAS RESIDUE FROM A VIAL RUBBER STOPPER INSIDE THE MEDICATION. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE WITH SOLUTION IN IT AND A GRAY COLORED PARTICLE THAT IS HIGHLIGHTED WITH A RED CIRCLE. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303345, LOT 4060239. 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 PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    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#: 303345. BATCH NUMBER#: 4060239. VERBATIM#: ISSUE: RESIDUE FROM RUBBER STOPPER ON MEDICATION VIAL INSIDE MEDICATION THAT WAS GOING TO BE INFUSED INTO A PATIENT. THIS COULD POSE A SERIOUS EVENT TO PATIENT IF IT HAD NOT BEEN SEEN BY THE LPN. THIS WAS AFTER USING THE BD BLUNT PLASTIC CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851224 CANNULA BLUNT PLASTIC NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4060239

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown