BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 10188074 · Received June 24, 2020

    Report

    Report Number
    9616656-2020-00586
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    June 3, 2020
    Report Date
    July 7, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403801518
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 6/29/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (3) SEALED 8MM, 31G PEN NEEDLES FROM LOT # 8100752. CUSTOMER STATES THAT THERE IS IRREGULAR BLOOD SUGAR NUMBERS RECENTLY WITH THE PEN NEEDLES FROM CURRENT LOT #, PAIN WITH INJECTIONS IN THE STOMACH AREA AND SHE ALSO NOTICED INSULIN RUNNING DOWN FROM THE INJECTION SITE SO CONSUMER IS UNSURE IF SHE IS GETTING HER FULL MEDICATION DOSE. ALL RETURNED PEN NEEDLES WERE TESTED FOR POINT GEOMETRY, LUBE, AND CANNULA OD. THE FOLLOWING WAS OBSERVED (SPECS: OUTER DIAMETER FOR 31G: 0.0100¿-0.0105¿): DATA: POINT OUTER DIAMETER (IN) LUBE SAMPLE 1 GOOD, 0.0102 , GOOD, SAMPLE 2 GOOD, 0.0102 , GOOD, SAMPLE 3 GOOD, 0.0102 , GOOD, ALL SAMPLES WERE ALSO TESTED AND ALL WERE ABLE TO EXPEL PROPERLY. NO DEFECTS WERE OBSERVED ON ANY OF THE RETURNED SAMPLES. 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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES INSULIN IS RUNNING DOWN FROM THE INJECTION SITE AND THE CONSUMER IS UNSURE IF SHE'S GETTING THE FULL DOSE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320109 BATCH NO: 8100752 IT WAS REPORTED IRREGULAR BLOOD SUGAR NUMBERS RECENTLY WITH THE PEN NEEDLES FROM CURRENT LOT #, PAIN WITH INJECTIONS IN THE STOMACH AREA AND SHE ALSO NOTICED INSULIN RUNNING DOWN FROM THE INJECTION SITE SO CONSUMER IS UNSURE IF SHE IS GETTING HER FULL MEDICATION DOSE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES INSULIN IS RUNNING DOWN FROM THE INJECTION SITE AND THE CONSUMER IS UNSURE IF SHE'S GETTING THE FULL DOSE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320109, BATCH NO: 8100752. IT WAS REPORTED IRREGULAR BLOOD SUGAR NUMBERS RECENTLY WITH THE PEN NEEDLES FROM CURRENT LOT #, PAIN WITH INJECTIONS IN THE STOMACH AREA AND SHE ALSO NOTICED INSULIN RUNNING DOWN FROM THE INJECTION SITE SO CONSUMER IS UNSURE IF SHE IS GETTING HER FULL MEDICATION DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652006 BD ULTRA FINE PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8015 8100752 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Other