BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PEN NEEDLE

    MDR report key: 11458115 · Received March 10, 2021

    Report

    Report Number
    9616656-2021-00239
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 11, 2021
    Report Date
    April 9, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320144 BATCH NO. 0231140. GOOD DAY, I AM EMAILING TO EXPRESS AN ISSUE WE HAVE WITH THE BD ULTRA-FINE PEN NEEDLES (BD NANO 4MM X 32G) WHICH MY HUSBAND USES DAILY. HE NEEDS 4 INJECTIONS PER DAY SO AS A RESULT HE USES QUITE A NUMBER OF THESE NEEDLES ON A MONTHLY BASIS. LATELY WE HAVE EXPERIENCED ISSUES WITH THE NEEDLES WHICH OFTEN RESULTS IN NEEDING TO USE 2 OR 3 NEEDLES IN ORDER TO ADMINISTER ONE INJECTION. THE ISSUE OF CONCERN IS THAT THE PEN WILL NOT RELEASE THE INSULIN THROUGH THE NEEDLE, WHICH CAUSES US TO ATTACH A SECOND NEEDLE AND SOMETIMES A THIRD BEFORE WE ACHIEVE THE INTENDED DOSAGE OF INSULIN. I ASSURE YOU IT IS NOT THE PEN THAT'S THE ISSUE AS WE HAVE BEEN IN CONTACT WITH THE MANUFACTURER AND HAVE TESTED THE PENS TO ENSURE EASY DIAL UP AND RELEASE WHEN WE HAVE ATTACHED A WORKING NEEDLE. WHEN WE'VE EXPERIENCED ISSUES WITH THE DELIVERY OF INSULIN AND THEN CHANGED THE NEEDLE, THE PEN WORKED AS IT SHOULD.I AM REACHING OUT TO YOU REGARDING THIS BECAUSE I DON'T THINK WE SHOULD BE LOSING NEEDLES IN THIS WAY. WITH 100 NEEDLES PER BOX AND MY HUSBAND NEEDING 4 INJECTIONS DAILY, A BOX OF NEEDLES DON'T EVEN LAST ONE MONTH. THEN WHEN WE FACTOR IN UNWORKABLE NEEDLES, THE NEED TO PURCHASE MORE INCREASES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PEN NEEDLE WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320144, BATCH NO. 0231140. GOOD DAY, I AM EMAILING TO EXPRESS AN ISSUE WE HAVE WITH THE BD ULTRA-FINE PEN NEEDLES (BD NANO 4MM X 32G) WHICH MY HUSBAND USES DAILY. HE NEEDS 4 INJECTIONS PER DAY SO AS A RESULT HE USES QUITE A NUMBER OF THESE NEEDLES ON A MONTHLY BASIS. LATELY WE HAVE EXPERIENCED ISSUES WITH THE NEEDLES WHICH OFTEN RESULTS IN NEEDING TO USE 2 OR 3 NEEDLES IN ORDER TO ADMINISTER ONE INJECTION. THE ISSUE OF CONCERN IS THAT THE PEN WILL NOT RELEASE THE INSULIN THROUGH THE NEEDLE, WHICH CAUSES US TO ATTACH A SECOND NEEDLE AND SOMETIMES A THIRD BEFORE WE ACHIEVE THE INTENDED DOSAGE OF INSULIN. I ASSURE YOU IT IS NOT THE PEN THAT'S THE ISSUE AS WE HAVE BEEN IN CONTACT WITH THE MANUFACTURER AND HAVE TESTED THE PENS TO ENSURE EASY DIAL UP AND RELEASE WHEN WE HAVE ATTACHED A WORKING NEEDLE. WHEN WE'VE EXPERIENCED ISSUES WITH THE DELIVERY OF INSULIN AND THEN CHANGED THE NEEDLE, THE PEN WORKED AS IT SHOULD. I AM REACHING OUT TO YOU REGARDING THIS BECAUSE I DON'T THINK WE SHOULD BE LOSING NEEDLES IN THIS WAY. WITH 100 NEEDLES PER BOX AND MY HUSBAND NEEDING 4 INJECTIONS DAILY, A BOX OF NEEDLES DON'T EVEN LAST ONE MONTH. THEN WHEN WE FACTOR IN UNWORKABLE NEEDLES, THE NEED TO PURCHASE MORE INCREASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349475 BD ULTRA-FINE PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 0231140

    Patients

    Seq Age Sex Outcome Treatment
    1