BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17188140 · Received June 22, 2023

    Report

    Report Number
    9616656-2023-00632
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    May 31, 2023
    Report Date
    July 6, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: D4: MEDICAL DEVICE LOT #: 2180169; D4: MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2027; H4: DEVICE MANUFACTURE DATE: 29-JUN-2022. H6: INVESTIGATION SUMMARY ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 2180169, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND PHOTOS AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED. DUE TO THE CONDITION THE SAMPLE WAS RETURNED NO CLOG TEST COULD BE CARRIED OUT. AS THE SAMPLE RETURNED WAS OPEN IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D.4 DEVICE EXPIRATION DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 OF THE BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM WERE DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: (NO DRUG SOLUTION WAS COMING OUT).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 OF THE BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM WERE DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: (NO DRUG SOLUTION WAS COMING OUT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854442 BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2180169

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown