BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PRO PEN NEEDLES

    MDR report key: 18322717 · Received December 13, 2023

    Report

    Report Number
    9616656-2023-01238
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 7, 2023
    Report Date
    December 15, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 3025245 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2028 H.4. DEVICE MANUFACTURE DATE: 25-JAN2023 D.4. MEDICAL DEVICE LOT #: 3080897 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2028 H.4. DEVICE MANUFACTURE DATE: 21-MAR-2023 E.1. INITIAL REPORTER PHONE#: (B)(4). 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 WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 07-NOV-2023 . H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER 3025245 AND THE 2ND COMPLAINT FOR THE REPORTED LOT NUMBER 3080897. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AS BENT NPE CANNULA AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. 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 WHILE USING THE BD ULTRA-FINE¿ PRO PEN NEEDLES 32G X 4MM (105 COUNT) THERE WAS NEEDLE WAS CLOGGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTED: NEEDLES ARE IMPERMEABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD ULTRA-FINE¿ PRO PEN NEEDLES 32G X 4MM (105 COUNT) THERE WAS NEEDLE WAS CLOGGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTED: NEEDLES ARE IMPERMEABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273159 BD ULTRA-FINE¿ PRO PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown