BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLES

    MDR report key: 17056136 · Received June 2, 2023

    Report

    Report Number
    9616656-2023-00535
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 16, 2023
    Report Date
    September 21, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: 04-JUL-2023. 95 SEALED 31G X 8MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 2284608, CAT. NO. 320524. A CLOG TEST WAS CARRIED OUT ON 30 OF THE RETURNED SAMPLES AND NO ISSUES WERE OBSERVED. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLES WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: PHARMACY INFORMED US, THAT A PATIENT COMPLAINED ABOUT CLOGGED PEN-NEEDLES. THE NEEDLES WOULDNT LET THE INSULIN THROUGH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLES WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: PHARMACY INFORMED US, THAT A PATIENT COMPLAINED ABOUT CLOGGED PEN-NEEDLES. THE NEEDLES WOULD NOT LET THE INSULIN THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218992 BD ULTRA-FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2284608

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown