BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTERLINK BLUNT PLASTIC CANNULA

    MDR report key: 12248028 · Received July 29, 2021

    Report

    Report Number
    1911916-2021-00750
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    June 30, 2021
    Report Date
    July 18, 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1015092, MEDICAL DEVICE EXPIRATION DATE: 2026-03-31, DEVICE MANUFACTURE DATE: 2021-01-15, MEDICAL DEVICE LOT #: 8090585, MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, DEVICE MANUFACTURE DATE: 2018-03-31. MEDICAL DEVICE LOT #: 1096756, MEDICAL DEVICE EXPIRATION DATE: 2026-04-30, DEVICE MANUFACTURE DATE: 2021-04-06. INVESTIGATION SUMMARY: IT WAS REPORTED BY THE DISTRIBUTOR THAT PIECES OF THE RUBBER FROM THE VIAL ARE BEING SHEARED OFF BY THE CANNULA AND DRAWN UP. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A VIAL OF PROPOFOL WITH A RED ARROW INDICATING A FOREIGN MATTER INSIDE THE VIAL. THIS DEFECT CAN OCCUR IF THE PRODUCT IS NOT BEING USED AS INTENDED. THE PLASTIC NEEDLE PRODUCT IS NOT DESIGNED TO BE USED WITH THESE VIALS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303345, LOT NUMBERS 1015092, 8090585 AND 1096756. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTERLINK¿ BLUNT PLASTIC CANNULA SHEARED THE TOP OF THE RUBBER VIAL OFF INTO THE MEDICATION DURING USE. THIS HAPPENED 2 TIMES EACH IN LOTS 1015092, 8090585, AND 1096756. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RUBBER FROM TOP OF VIAL WAS SHEARED OFF WITH CANNULA AND COULD POTENTIALLY BE DRAWN UP INTO SYRINGE AND INJECTED INTO THE PATIENT IF NOT NOTICED BY CRNA." "THE RUBBER FROM THE TOP OF THE MEDICATION VIAL IS BEING SHEARED OFF WITH THE CANNULA AND GOING INTO THE MEDICATION VIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145291 BD INTERLINK BLUNT PLASTIC CANNULA HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 303345 SEE SECTION H.10. 30382903033455

    Patients

    Seq Age Sex Outcome Treatment
    1