BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTERLINK¿ BLUNT PLASTIC CANNULA

    MDR report key: 13982599 · Received April 1, 2022

    Report

    Report Number
    1911916-2022-00179
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 4, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED BY THE CONSUMER SMALL RUBBER PIECE AT BOTTOM OF MEDICATION VIAL. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A VIAL WITH A WHITE SOLUTION IN IT. AT THE BOTTOM OF THE VIAL IS A SMALL DARK PARTICLE. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303345, LOT NUMBER 1260085. 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 PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD INTERLINK¿ BLUNT PLASTIC CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ACCESSING/DRAWING UP MEDICATION IS PUSHING A PIECE OF RUBBER INTO THE MEDICATION VIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD INTERLINK¿ BLUNT PLASTIC CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ACCESSING/DRAWING UP MEDICATION IS PUSHING A PIECE OF RUBBER INTO THE MEDICATION VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838051 BD INTERLINK¿ BLUNT PLASTIC CANNULA HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 303345 1260085 30382903033455

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown