BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 18440228 · Received January 3, 2024

    Report

    Report Number
    9616656-2023-01295
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    December 4, 2023
    Report Date
    February 1, 2024
    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

    H.3. 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

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: PATIENT INFORMED US THAT EVERY THIRD NEEDLE OF 320522, LOT 3172407 WOULD NOT LET LIQUID FLOW THROUGH. SHE EXPERIENCED THIS ALSO WITH FORMER BOXES BUT NOT TO THE SAME DEGREE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: PATIENT INFORMED US THAT EVERY THIRD NEEDLE OF 320522, LOT 3172407 WOULD NOT LET LIQUID FLOW THROUGH. SHE EXPERIENCED THIS ALSO WITH FORMER BOXES BUT NOT TO THE SAME DEGREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492397 BD ULTRA-FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3172407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown