BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ III PEN NEEDLE

    MDR report key: 13693685 · Received March 8, 2022

    Report

    Report Number
    2243072-2022-00312
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 28, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 9253730; D4: MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2024; H4: DEVICE MANUFACTURE DATE: 01-SEP-2020. D4: MEDICAL DEVICE LOT #: 9148683; D4: MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2024; H4: DEVICE MANUFACTURE DATE: 01-SEP-2020. H6: INVESTIGATION SUMMARY NO PHYSICAL SAMPLES WERE RECEIVED; THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO PROVIDED. 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. THE COMPLAINT COULD NOT BE CONFIRMED HENCE THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 50 BD ULTRA-FINE¿ III PEN NEEDLES EXPERIENCED INCORRECT LABEL INFORMATION, AND A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHELF CARTON AND POUCH HAS BD ULTRA-FINETM III BRAND NAME. HOWEVER, TEAR DROP LABEL MENTIONS BD MICRO-FINE+, PENTA POINT TECHNOLOGY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 50 BD ULTRA-FINE¿ III PEN NEEDLES EXPERIENCED INCORRECT LABEL INFORMATION, AND A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHELF CARTON AND POUCH HAS BD ULTRA-FINETM III BRAND NAME. HOWEVER, TEAR DROP LABEL MENTIONS BD MICRO-FINE+, PENTA POINT TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932390 BD ULTRA-FINE¿ III PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown