BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 4MM PEN NEEDLE

    MDR report key: 13459052 · Received February 4, 2022

    Report

    Report Number
    9616656-2022-00108
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 24, 2022
    Report Date
    April 26, 2022
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY FOUR PHOTOS AND ONE OPEN 34G X 4MM PEN NEEDLE SAMPLE WERE RETURNED FROM AN UNKNOWN LOT. NO., CAT. NO. 320623. A FUNCTIONALITY TEST AS PER Q-SOP-183-DL WAS CARRIED OUT ON THE RETURNED SAMPLE AND A LOOSE HUB IN COVER WAS OBSERVED. A REVIEW OF EWO-20-147P WAS CARRIED OUT NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS DEFECT AND ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. THIS ISSUE WAS CAUSED BY AN INTERFERENCE FIT BETWEEN THE HUB AND THE COVER. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 4MM PEN NEEDLE WAS UNABLE TO BE REMOVED FROM THE PEN, AND THE PEN NEEDLE BEING UNABLE TO DETACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER REPORT THAT IT WAS DIFFICULT TO DETACH THE PEN NEEDLE FROM THE PEN WITH THE NEEDLE CASE UPRIGHT. THIS WAS FOR MARKET RESEARCH ONLY. THE PATIENT DID NOT INJECT INTO THEIR BODY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 4MM PEN NEEDLE WAS UNABLE TO BE REMOVED FROM THE PEN, AND THE PEN NEEDLE BEING UNABLE TO DETACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER REPORT THAT IT WAS DIFFICULT TO DETACH THE PEN NEEDLE FROM THE PEN WITH THE NEEDLE CASE UPRIGHT. THIS WAS FOR MARKET RESEARCH ONLY. THE PATIENT DID NOT INJECT INTO THEIR BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649779 BD 4MM PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown