BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 15530503 · Received October 3, 2022

    Report

    Report Number
    9616656-2022-01078
    Event Type
    Malfunction
    Date Received
    October 3, 2022
    Date of Event
    September 8, 2022
    Report Date
    May 21, 2024
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4. MEDICAL DEVICE LOT #: 1154037. D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026. H4. DEVICE MANUFACTURE DATE: 29-NOV-2021. D4. MEDICAL DEVICE LOT #: 1033283. D4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2026. H4. DEVICE MANUFACTURE DATE: 30-SEP-2021. D4. MEDICAL DEVICE LOT #: 1186383. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2026. H4. DEVICE MANUFACTURE DATE: 30-DEC-2021.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST RELATED 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. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE HENCE THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    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 5 BD ULTRA-FINE¿ PEN NEEDLE SNAPPED OFF AND IN THE RUBBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED WHILE USING OPTILIN JUNIOR STAR INSULIN PEN THAT THE INNER NEEDLE SNPPED OFF AND WAS IN RUBBER BUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD ULTRA-FINE¿ PEN NEEDLE SNAPPED OFF AND IN THE RUBBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED WHILE USING OPTILIN JUNIOR STAR INSULIN PEN THAT THE INNER NEEDLE SNPPED OFF AND WAS IN RUBBER BUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD ULTRA-FINE¿ PEN NEEDLE SNAPPED OFF AND IN THE RUBBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED WHILE USING OPTILIN JUNIOR STAR INSULIN PEN THAT THE INNER NEEDLE SNPPED OFF AND WAS IN RUBBER BUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335486 BD ULTRA-FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown