BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTERLINK¿ BLUNT PLASTIC CANNULA

    MDR report key: 17121338 · Received June 13, 2023

    Report

    Report Number
    1911916-2023-00394
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 22, 2023
    Report Date
    July 6, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903033454
    PMA / PMN Number
    K974363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED A RUBBER CORE APPEARED IN THE MEDICATION AFTER THE RUBBER CAP WAS SPIKED. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS A SYRINGE WITH A PLASTIC NEEDLE INSERTED INTO A VIAL. THE OTHER PHOTO SHOWS A PARTICLE INSIDE THE VIAL THAT APPEARS TO BE A SIMILAR COLOR TO THE VIAL STOPPER. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. IT COULD BE POSSIBLE THE CUSTOMER IS NOT USING THE PRODUCT AS INTENDED. PER THE PRODUCT SPECIFICATION, "BD BLUNT PLASTIC CANNULA PROVIDES STERILE NEEDLELESS ACCESS INTO PRE-SLIT SEPTUM IV SYSTEMS AND VIALS DESIGNED FOR NEEDLELESS ACCESS." THIS UNIT IS NOT FOR USE WITH REGULAR VIALS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303345, LOT 1260085. 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 PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTERLINK¿ BLUNT PLASTIC CANNULA EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN ISSUE WAS OBSERVED TODAY WHEN USING ONE OF THE NEW VIAL ASPIRATOR NEEDLES ¿ A RUBBER CORE APPEARED IN THE MEDICATION AFTER THE RUBBER CAP WAS SPIKED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTERLINK¿ BLUNT PLASTIC CANNULA EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN ISSUE WAS OBSERVED TODAY WHEN USING ONE OF THE NEW VIAL ASPIRATOR NEEDLES. A RUBBER CORE APPEARED IN THE MEDICATION AFTER THE RUBBER CAP WAS SPIKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998460 BD INTERLINK¿ BLUNT PLASTIC CANNULA HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 1260085 00382903033454

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown