BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PEN NEEDLE

    MDR report key: 11335512 · Received February 16, 2021

    Report

    Report Number
    9616656-2021-00152
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    January 22, 2021
    Report Date
    April 23, 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

    H.6. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD ULTRA-FINE¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320144 BATCH NO: 0231140 AND 0091873 CONSUMER REPORTED HAVING PEN NEEDLES THAT ARE NOT WORKING. STATED NO MEDICATION COMES OUT OF THE PEN NEEDLES DURING INJECTION. CONSUMER DOES NOT PRIME. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0091873, MEDICAL DEVICE EXPIRATION DATE: 2025-03-31, DEVICE MANUFACTURE DATE: 2020-03-31, MEDICAL DEVICE LOT #: 0231140, MEDICAL DEVICE EXPIRATION DATE: 2025-08-31, DEVICE MANUFACTURE DATE: 2020-08-18. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD ULTRA-FINE¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320144, BATCH NO: 0231140 AND 0091873. CONSUMER REPORTED HAVING PEN NEEDLES THAT ARE NOT WORKING. STATED NO MEDICATION COMES OUT OF THE PEN NEEDLES DURING INJECTION. CONSUMER DOES NOT PRIME. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228376 BD ULTRA-FINE PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 0231140

    Patients

    Seq Age Sex Outcome Treatment
    1