BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA BLUNT PLASTIC

    MDR report key: 11944305 · Received June 5, 2021

    Report

    Report Number
    1911916-2021-00524
    Event Type
    Malfunction
    Date Received
    June 5, 2021
    Date of Event
    May 7, 2021
    Report Date
    May 25, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903033455
    PMA / PMN Number
    K974363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT A PIECE OF THE SYRINGE/CANNULA BREAKS OFF AND IT IS DIFFICULT TO PUSH THE CANNULA THROUGH. TO AID IN THE INVESTIGATION THREE HUNDRED SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. TWO HUNDRED NINETY-NINE SAMPLES ARE IN SEALED PACKAGING BLISTERS AND ONE CAME WITH NO PACKAGING BLISTER. SIXTY RANDOM SAMPLES WERE RANDOMLY SELECTED FOR A VISUAL INSPECTION AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THE CUSTOMER IS NOT USING THE PRODUCT AS INTENDED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303345, LOT NUMBER 0252728. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CANNULA BLUNT PLASTIC WAS FOUND TO HAVE FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "PER RESPONSE EMAIL: THESE DEVICES WERE BEING USED ON THE RUBBER VIAL STOPPERS TO PULL UP THE MEDICATION, NOT THE ACTUAL CAP. THEY WERE EXTREMELY HARD TO PUSH IN AND WHEN WE DID GET THEM IN THE VIALS, THERE WERE VISIBLE FRAGMENTS IN VIAL AND PULLED UP INTO THE SYRINGE. HELLO, WE ARE IN CRITICAL NEED OF SOME 3ML CANNULAS. THESE LOOK PROMISING BELOW AS WE HAVE HAD SOME CONCERNING ISSUES REGARDING REF# 303346. IT HAS BEEN REPORTED BY END USERS OF MULTIPLE INSTANCES WHERE A PIECE OF THE SYRINGE/CANNULA BREAKS OFF. THE 303346 SYRINGES ARE ALSO VERY DIFFICULT TO USE AND PART OF THE INSTANCE MAY BE THE FORCE REQUIRED TO PUSH THE CANNULA THROUGH, WHICH LEADS TO PIECES OF THE SYRINGE AND OR RUBBER MEDICATION COVER BREAKING OFF AND GOING INTO THE VIAL AND/OR SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840690 CANNULA BLUNT PLASTIC HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 303345 0252728 30382903033455

    Patients

    Seq Age Sex Outcome Treatment
    1