BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PEN NEEDLE

    MDR report key: 10786094 · Received November 4, 2020

    Report

    Report Number
    9616656-2020-01099
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 15, 2020
    Report Date
    April 15, 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
    003

    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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LANTUS INSULIN WOULD NOT FLOW THROUGH THE BD ULTRA-FINE¿ PEN NEEDLES DURING THE INJECTIONS AND FLOW CHECK. LOTS 8197889, 0091873. AND AN UNSPECIFIED LOT EACH HAD 1 OCCURRENCE OF THESE EVENTS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER WIFE REPORTED FINDING LANTUS WILL NOT GO THRU THE NEEDLES DURING FLOW CHECK AND INJECTIONS. CLAIMS LEAVING BRUISES AND BUMPS ON HUSBANDS TUMMY. DENIED REUSE OF PEN NEEDLES. CLAIMS DOES THE FLOW CHECK SEES CLOGS DURING FLOW CHECK AND INJECTION. INFORMED OF NON PATIENT END PLACEMENT CALLER DID NOT LIKE THIS PROCESS".

    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 #: 8197889, MEDICAL DEVICE EXPIRATION DATE: 2023-07-31, DEVICE MANUFACTURE DATE: 2018-07-16, MEDICAL DEVICE LOT #: 0091873, MEDICAL DEVICE EXPIRATION DATE: 2025-03-31, DEVICE MANUFACTURE DATE: 2020-03-31, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. 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 LANTUS INSULIN WOULD NOT FLOW THROUGH THE BD ULTRA-FINE¿ PEN NEEDLES DURING THE INJECTIONS AND FLOW CHECK. LOTS 8197889, 0091873. AND AN UNSPECIFIED LOT EACH HAD 1 OCCURRENCE OF THESE EVENTS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER WIFE REPORTED FINDING LANTUS WILL NOT GO THRU THE NEEDLES DURING FLOW CHECK AND INJECTIONS. CLAIMS LEAVING BRUISES AND BUMPS ON HUSBANDS TUMMY. DENIED REUSE OF PEN NEEDLES. CLAIMS DOES THE FLOW CHECK SEES CLOGS DURING FLOW CHECK AND INJECTION. INFORMED OF NON PATIENT END PLACEMENT CALLER DID NOT LIKE THIS PROCESS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254245 BD ULTRA-FINE PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1