BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLE

    MDR report key: 17568863 · Received August 17, 2023

    Report

    Report Number
    9616656-2023-00913
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    July 21, 2023
    Report Date
    September 1, 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

    INVESTIGATION SUMMARY: THREE OPEN 32G X 4MM PEN NEEDLE SAMPLES AND THREE PHOTOS WERE RETURNED FROM AN UNKNOWN LOT NO., CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON TWO SAMPLES AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON THE REMAINING SAMPLE. DUE TO THE CONDITION OF THE RETURNED SAMPLES NO CLOG TEST COULD BE CARRIED OUT. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT THE NON-PATIENT END OF THE BD MICRO-FINE¿ PRO PEN NEEDLE WAS BROKEN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT IS ABOUT NEEDLE CLOG. THE PATIENT COMPLAINED THAT THE NEEDLE WAS ATTACHED TO THE SYRINGE, BUT NO DRUG SOLUTION CAME OUT. ABOUT 2 NEEDLES WERE REPLACED AND USED. THE SAME CASE OCCURRED ON JULY 12 WITH ANOTHER PATIENT." VIA BDJ INVESTIGATION TEAM: "3 DEFECT SAMPLES WERE RETURNED. BDJ FOUND 2 NP NEEDLE BENT AND 1 NP NEEDLE BROKEN."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NON-PATIENT END OF THE BD MICRO-FINE¿ PRO PEN NEEDLE WAS BROKEN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT IS ABOUT NEEDLE CLOG. THE PATIENT COMPLAINED THAT THE NEEDLE WAS ATTACHED TO THE SYRINGE, BUT NO DRUG SOLUTION CAME OUT. ABOUT 2 NEEDLES WERE REPLACED AND USED. THE SAME CASE OCCURRED ON JULY 12 WITH ANOTHER PATIENT." VIA BDJ INVESTIGATION TEAM: "3 DEFECT SAMPLES WERE RETURNED. BDJ FOUND 2 NP NEEDLE BENT AND 1 NP NEEDLE BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246530 BD MICRO-FINE¿ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown