BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31G 5MM

    MDR report key: 9180457 · Received October 11, 2019

    Report

    Report Number
    8041187-2019-00810
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 26, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    10885403897504
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 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 5 PEN NDL 31G 5MM EXPERIENCED INABILITY OR DIFFICULT TO PRIME DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320882, BATCH NO. 8231386. ISSUE(S): NEEDLE CLOGGED DURING FLOW CHECK WITH INSULIN. FOUND 5 PEN NEEDLES 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 5 PEN NDL 31G 5MM EXPERIENCED INABILITY OR DIFFICULT TO PRIME DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320882. BATCH NO. 8231386. ISSUE(S): NEEDLE CLOGGED DURING FLOW CHECK WITH INSULIN. FOUND 5 PEN NEEDLES DATE OF EVENT: UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977071 PEN NDL 31G 5MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8231386 10885403897504

    Patients

    Seq Age Sex Outcome Treatment
    1 Other