BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ACCU-FINE® PEN NEEDLE

    MDR report key: 15663686 · Received October 24, 2022

    Report

    Report Number
    9616656-2022-01132
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    September 28, 2022
    Report Date
    November 12, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 28-OCT-2022. H6: INVESTIGATION SUMMARY: SEVENTY FOUR SEALED 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 1160325 ALONG WITH SIXTY SEALED 32G X 4MM PEN NEEDLE SAMPLES FROM LOT. NO. 0119879. VISUAL EXAMINATION WAS CARRIED OUT ON 30 SAMPLES FROM LOT. NO. 1160325 AND 30 SAMPLES FROM LOT. NO. 0119879 AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0119879 (INVALID LOT #). MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: NA. MEDICAL DEVICE LOT #: 1160325(INVALID LOT #). MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: NA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ACCU-FINE® PEN NEEDLES BREAKS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: NEEDLES BREAK DURING USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ACCU-FINE® PEN NEEDLES BREAKS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: NEEDLES BREAK DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370503 BD ACCU-FINE® PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown