BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO

    MDR report key: 12595719 · Received October 8, 2021

    Report

    Report Number
    9616656-2021-01252
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 9, 2021
    Report Date
    October 8, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUATION? YES. D10: RETURNED TO MANUFACTURER ON: 2021-10-06 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (13) OPEN 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. THE CONSUMER REPORTED THAT THERE IS NO INSULIN FLOW DURING PRIMING. ALL 13 RETURNED PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT 8 EXHIBITED A BENT NON-PATIENT END (NPE) CANNULA, AND 3 EXHIBITED A BROKEN NPE CANNULA. THE REMAINING 2 PEN NEEDLES EXHIBITED A STRAIGHT NPE CANNULA, AND BOTH WERE TESTED FOR FLOW USING A TEST PEN INJECTOR: BOTH WERE ABLE TO EXPEL PROPERLY. THE BENT AND BROKEN NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THAT THE PEN NEEDLES WERE CLOGGED. SINCE ALL 13 PEN NEEDLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT AND BROKEN NPE CANNULAS IS USER RELATED. 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. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NPE CANNULA BENT, NPE CANNULA BROKEN) THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE NPE CANNULAS WERE BENT AND BROKEN AFTER THE CUSTOMER HANDLED THE PEN NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED PEN NDL 32G 4MM PRO WOULD NOT DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I RETURNED CONSUMER'S CALL, SHE STATED THAT THERE IS NO INSULIN FLOW DURING PRIMING."

    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 PEN NDL 32G 4MM PRO WOULD NOT DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I RETURNED CONSUMER'S CALL, SHE STATED THAT THERE IS NO INSULIN FLOW DURING PRIMING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494677 PEN NDL 32G 4MM PRO PEN NEEDLE FMI BECTON DICKINSON AND CO. 0336663

    Patients

    Seq Age Sex Outcome Treatment
    1