BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLES

    MDR report key: 18390572 · Received December 25, 2023

    Report

    Report Number
    2243072-2023-02241
    Event Type
    Malfunction
    Date Received
    December 25, 2023
    Date of Event
    November 30, 2023
    Report Date
    February 1, 2024
    Manufacturer
    BECTON DICKINSON
    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

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES NO D9: RETURNED TO MANUFACTURER ON: 20DEC2023 H.6. INVESTIGATION SUMMARY SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM (70 COUNT) WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: NEEDLE BENDING ON THE REAR NEEDLE SIDE. BENT NEEDLE ON THE POSTERIOR NEEDLE SIDE. IT WAS SAID THAT THE PATIENT COULD NOT USE IT, SO BROUGHT IT WITH HIM. (B)(6) 2023 38 DEFECT SAMPLES WERE RETURNED. BDJ CONFIRMED 33 NP NEEDLE BENT AND 5 NP NEEDLE BROKEN. PICTURES FOR THE RETURNED SAMPLE ARE ATTACHED. SAMPLE WILL BE SENT. ROW#2 WAS ADDED FOR "NP NEEDLE BROKEN" AFTER THE ACTUAL SAMPLE WAS RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ PRO PEN NEEDLES 32G X 4MM (70 COUNT) WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: NEEDLE BENDING ON THE REAR NEEDLE SIDE. BENT NEEDLE ON THE POSTERIOR NEEDLE SIDE. IT WAS SAID THAT THE PATIENT COULD NOT USE IT, SO BROUGHT IT WITH HIM. 12/19/2023 38 DEFECT SAMPLES WERE RETURNED. BDJ CONFIRMED 33 NP NEEDLE BENT AND 5 NP NEEDLE BROKEN. PICTURES FOR THE RETURNED SAMPLE ARE ATTACHED. SAMPLE WILL BE SENT. ROW#2 WAS ADDED FOR "NP NEEDLE BROKEN" AFTER THE ACTUAL SAMPLE WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2266663 BD MICRO-FINE¿ PRO PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown