BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM (70 COUNT)

    MDR report key: 17132156 · Received June 14, 2023

    Report

    Report Number
    9616656-2023-00587
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 23, 2023
    Report Date
    July 13, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 07-JUL-2023 H6: INVESTIGATION SUMMARY THIRTEEN SEALED 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 2172163 ALONG WITH FOURTEEN SEALED 32G X 4MM PEN NEEDLE SAMPLES FROM LOT. NO. 2165552, CAT. NO. 320559. A CLOG TEST WAS CARRIED OUT ON THE THIRTEEN SEALED SAMPLES FROM LOT. NO. 2172163 AND THE FOURTEEN SEALED SAMPLES FROM LOT. NO. 2165552 AS PER Q-SOP-183-DL AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. SEE H10.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D.4 DEVICE EXPIRATION DATE: UNKNOWN; H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM (70 COUNT) WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT THE NEEDLE CLOG. SEVERAL USERS WITH INSULIN GLARGINE PRESCRIPTION REPORTED THAT THE DRUG SOLUTION DID NOT COME OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM (70 COUNT) WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT THE NEEDLE CLOG. SEVERAL USERS WITH INSULIN GLARGINE PRESCRIPTION REPORTED THAT THE DRUG SOLUTION DID NOT COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409440 BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM (70 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown