BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NEEDLE¿ ULTRA-FINE III

    MDR report key: 8577776 · Received May 3, 2019

    Report

    Report Number
    9616656-2019-00411
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    April 18, 2019
    Report Date
    May 24, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEN NEEDLE¿ ULTRA-FINE III NEEDLE BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320108, BATCH NO. 8143539. IT WAS REPORTED THAT THE NEEDLE BROKE OFF DURING USE. VERBATIM: UPDATE FROM CS0008012: FROM PHONE CALL ON (B)(6) 2019 11:34:03: CALLED CONSUMER FOR ADDITIONAL INFORMATION. STATED THAT THE NEEDLE BROKE OFF JUST AS THE NEEDLE TOUCHED HIS SKIN, IT DID NOT GO INTO HIS SKIN. HE REMOVED THE NEEDLE AND SAVED IT. THIS OCCURRED ABOUT TWO WEEKS AGO. CONSUMER DOES NOT RE-USE, SAID HE IS A LONG TIME USER OF PEN NEEDLES. NO INJURY OCCURRED, NO MEDICAL ATTENTION. PRODUCT # IS 320108. I WAS IN THE PROCESS OF INJECTING MYSELF WITH INSULIN USING A INSULIN PEN WHEN THE TIP OF THE NEEDLE TOUCHED MY SKIN IT BROKE OFF. THE NEEDLE IS A 0.25MM X 8MM (31G X 5/16") LOT 8143539, EXP 2023-05. I HAVE RETAINED THE BROKEN NEEDLE .

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PEN NEEDLE¿ ULTRA-FINE III NEEDLE BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320108 BATCH NO. 8143539. IT WAS REPORTED THAT THE NEEDLE BROKE OFF DURING USE. VERBATIM: UPDATE FROM CS0008012: FROM PHONE CALL ON 2019-04-26 11:34:03: CALLED CONSUMER FOR ADDITIONAL INFORMATION. STATED THAT THE NEEDLE BROKE OFF JUST AS THE NEEDLE TOUCHED HIS SKIN, IT DID NOT GO INTO HIS SKIN. HE REMOVED THE NEEDLE AND SAVED IT. THIS OCCURRED ABOUT TWO WEEKS AGO. CONSUMER DOES NOT RE-USE, SAID HE IS A LONG TIME USER OF PEN NEEDLES. NO INJURY OCCURRED, NO MEDICAL ATTENTION. PRODUCT # IS 320108. I WAS IN THE PROCESS OF INJECTING MYSELF WITH INSULIN USING A INSULIN PEN WHEN THE TIP OF THE NEEDLE TOUCHED MY SKIN IT BROKE OFF. THE NEEDLE IS A 0.25MM X 8MM (31G X 5/16") LOT 8143539 EXP 2023-05. I HAVE RETAINED THE BROKEN NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372284 BD PEN NEEDLE¿ ULTRA-FINE III INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 8143539

    Patients

    Seq Age Sex Outcome Treatment
    1 Other