BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ PEN NEEDLE

    MDR report key: 8387446 · Received March 4, 2019

    Report

    Report Number
    9616656-2019-00200
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    February 4, 2019
    Report Date
    April 5, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE RETURNED FOR ANALYSIS. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Additional Manufacturer Narrative · 0

    CORRECTION: DEVICE MANUFACTURE DATE: 2022-06-30 WAS CHANGED TO 2017-07-19.

    Additional Manufacturer Narrative · 0

    CORRECTION: TYPE OF DEVICE: N/A WAS CHANGED TO FMI. PMA / 510(K)#: N/A WAS CHANGED TO K162516.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWELVE BD NANO¿ PEN NEEDLE WERE CLOGGED. CUSTOMER¿S VERBATIM: ¿SINCE SEVERAL YEARS, I AM A USER OF BD PEN NEEDLES AND FROM THE LAST BOX I HAD TO THROW AWAY 12 NEEDLES WHICH WERE DEFECTIVE. CLOGGED NEEDLES. NO SAMPLES¿.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWELVE BD NANO¿ PEN NEEDLE WERE CLOGGED. CUSTOMER¿S VERBATIM: ¿SINCE SEVERAL YEARS, I AM A USER OF BD PEN NEEDLES AND FROM THE LAST BOX I HAD TO THROW AWAY 12 NEEDLES WHICH WERE DEFECTIVE. CLOGGED NEEDLES. NO SAMPLES¿.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWELVE BD NANO¿ PEN NEEDLE WERE CLOGGED. CUSTOMER¿S VERBATIM: ¿SINCE SEVERAL YEARS, I AM A USER OF BD PEN NEEDLES AND FROM THE LAST BOX I HAD TO THROW AWAY 12 NEEDLES WHICH WERE DEFECTIVE. CLOGGED NEEDLES. NO SAMPLES¿.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWELVE BD NANO¿ PEN NEEDLE WERE CLOGGED. CUSTOMER¿S VERBATIM: ¿SINCE SEVERAL YEARS, I AM A USER OF BD PEN NEEDLES AND FROM THE LAST BOX I HAD TO THROW AWAY 12 NEEDLES WHICH WERE DEFECTIVE. CLOGGED NEEDLES. NO SAMPLES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182180 BD NANO¿ PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 7200580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other