BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROFINE¿+ INSULIN SYRINGES

    MDR report key: 17740534 · Received September 13, 2023

    Report

    Report Number
    9616656-2023-00993
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 26, 2023
    Report Date
    September 14, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205615
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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 WHILE USING BD MICROFINE¿+ INSULIN SYRINGES THE MEDICATION COULD NOT PROPERLY BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT INFORMED US THAT SHE HAD NOW THREE BOXES OF PCN 320561 AND IN EVERY BOX WERE 4-5 PEN NEEDLES THAT DIDN'T ALLOW LIQUID TO FLOW THROUGH. THE PEN COULD NOT BE PUSHED. IN THE CURRENT BOX WITH LOT 3032948 THERE WERE 3 NEEDLES SO FAR.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROFINE¿+ INSULIN SYRINGES THE MEDICATION COULD NOT PROPERLY BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT INFORMED US THAT SHE HAD NOW THREE BOXES OF PCN 320561 AND IN EVERY BOX WERE 4-5 PEN NEEDLES THAT DIDN'T ALLOW LIQUID TO FLOW THROUGH. THE PEN COULD NOT BE PUSHED. IN THE CURRENT BOX WITH LOT 3032948 THERE WERE 3 NEEDLES SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061159 BD MICROFINE¿+ INSULIN SYRINGES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3032948 00382903205615

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown