BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLES 32G X 4MM

    MDR report key: 18216535 · Received November 28, 2023

    Report

    Report Number
    9616656-2023-01209
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    October 30, 2023
    Report Date
    November 30, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 3RD 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (100 COUNT) DURING THE FLOW CHECK 10-12 PEN WERE FOUND NEEDLES CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING DURING THE FLOW CHECK WITH THIS BOX, 10-12 PEN NEEDLES CLOGGED. DISCARDED THE SAMPLES. INFORMED OF THE PROPER PLACEMENT OF NON PATIENT END NEEDLES. LOT # 3011419. CATALOG# 320555.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (100 COUNT) DURING THE FLOW CHECK 10-12 PEN WERE FOUND NEEDLES CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING DURING THE FLOW CHECK WITH THIS BOX, 10-12 PEN NEEDLES CLOGGED. DISCARDED THE SAMPLES. INFORMED OF THE PROPER PLACEMENT OF NON PATIENT END NEEDLES. LOT # 3011419 CATALOG# 320555.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600972 BD NANO¿ PRO ULTRA-FINE¿ PEN NEEDLES 32G X 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3011419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown