BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PRO PEN NEEDLE

    MDR report key: 12754599 · Received November 4, 2021

    Report

    Report Number
    9616656-2021-01373
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    September 29, 2021
    Report Date
    December 21, 2021
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 11/23/2021. H.6. INVESTIGATION: FOUR OPEN AND FORTY TWO SEALED 32G X 4MM PEN NEEDLES SAMPLES WERE RETURNED FROM LOT. NO. 1033657, CAT. NO. 320561. VISUAL EXAMINATION AND A CLOG TEST AS PER TP700483 WAS CARRIED OUT ON THE FOUR OPEN SAMPLES AND TWENTY SIX OF THE SEALED SAMPLES 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 H3 OTHER TEXT : SEE H.10.

    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 THE BD ULTRA-FINE¿ PRO PEN NEEDLE WAS NOT PERMEABLE AND DIFFICULT TO USE AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "INJECTION CANNULAS ARE NOT PERMEABLE, NEEDLES DO NOT PIERCE OR ARE BENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PRO PEN NEEDLE WAS NOT PERMEABLE AND DIFFICULT TO USE AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "INJECTION CANNULAS ARE NOT PERMEABLE, NEEDLES DO NOT PIERCE OR ARE BENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649988 BD ULTRA-FINE¿ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1033657

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown