BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM HP

    MDR report key: 11566512 · Received March 24, 2021

    Report

    Report Number
    9616656-2021-00321
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    March 1, 2021
    Report Date
    April 16, 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

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NDL 32G 4MM HP WAS UNABLE OR DIFFICULT TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, NO INSULIN FLOW WHEN PRIMING. STATED, SOMETIMES IT TAKES 2 TO 3 PEN NEEDLES BEFORE IT WORKS. STATED, PRIMES 2 UNITS. LOT: 0070074. CATALOG: 320555. DATE OF EVENT: UNKNOWN.

    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 PEN NDL 32G 4MM HP WAS UNABLE OR DIFFICULT TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, NO INSULIN FLOW WHEN PRIMING. STATED, SOMETIMES IT TAKES 2 TO 3 PEN NEEDLES BEFORE IT WORKS. STATED, PRIMES 2 UNITS. LOT: 0070074, CATALOG: 320555, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456169 PEN NDL 32G 4MM HP PEN NEEDLE FMI BECTON DICKINSON AND CO. 0070074

    Patients

    Seq Age Sex Outcome Treatment
    1