BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO FINE¿ + PEN NEEDLE

    MDR report key: 16989070 · Received May 23, 2023

    Report

    Report Number
    9616656-2023-00507
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 1, 2023
    Report Date
    June 22, 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

    ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 2200693. D4: MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027. H4: DEVICE MANUFACTURE DATE: 19-JUL-2022.

    Additional Manufacturer Narrative · 0

    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 HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES, D.9. RETURNED TO MANUFACTURER ON: 05-JUN-2023. H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. EMBECTA WAS NOT 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 NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INNER SHIELD OF THE BD MICRO FINE¿ + PEN NEEDLE WOULD NOT DETACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THE USER REPORTED THAT THE INNER SHIELD WAS NOT REMOVED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INNER SHIELD OF THE BD MICRO FINE¿ + PEN NEEDLE WOULD NOT DETACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THE USER REPORTED THAT THE INNER SHIELD WAS NOT REMOVED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INNER SHIELD OF THE BD MICRO FINE¿ + PEN NEEDLE WOULD NOT DETACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THE USER REPORTED THAT THE INNER SHIELD WAS NOT REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218135 BD MICRO FINE¿ + PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2200693

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown