BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 17796033 · Received September 21, 2023

    Report

    Report Number
    9616656-2023-01023
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    September 7, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 3032945 FOR NEEDLE CLOG. THIS IS THE 1ST. RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 3032945. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4), REVISION 12, INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (NANO PRO PEN NEEDLE: NEEDLE CLOG) WAS CAPTURED AND ADDRESSED. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: - UNCONFIRMED: EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE LEAKED WHILE INJECTING INSULIN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLE CLOG WHEN HE TRIED TO TAKE HIS INJECTION TODAY STATED, NOTHING CAME OUT AND HIS BLOOD SUGAR WAS AT 300 1 PEN NEEDLE AFFECTED STATED, HE WILL REACH OUT TO HIS DOCTOR WENT OVER HOW TO TAKE INJECTION OVER THE PHONE. CONSUMER HAD A SUCCESSFUL PRIME AND INJECTION OF 15 UNITS BUT STATED, THERE WAS A LITTLE LEAKAGE AT THE END OF INJECTION. 1 PEN NEEDLE AFFECTED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE LEAKED WHILE INJECTING INSULIN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLE CLOG WHEN HE TRIED TO TAKE HIS INJECTION TODAY STATED, NOTHING CAME OUT AND HIS BLOOD SUGAR WAS AT 300 1 PEN NEEDLE AFFECTED STATED, HE WILL REACH OUT TO HIS DOCTOR WENT OVER HOW TO TAKE INJECTION OVER THE PHONE. CONSUMER HAD A SUCCESSFUL PRIME AND INJECTION OF 15 UNITS BUT STATED, THERE WAS A LITTLE LEAKAGE AT THE END OF INJECTION. 1 PEN NEEDLE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457802 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3032945 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown