BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO 2ND GEN PEN NEEDLE

    MDR report key: 14477832 · Received May 23, 2022

    Report

    Report Number
    9616656-2022-00578
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 21, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 31-MAY-2022 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A SINGLE 4MM, 32 GAUGE NANO PRO PEN NEEDLE FROM LOT 1132267. THE PATIENT SIDE OF THE PEN NEEDLE WAS PENT AT ITS BASE AT APPROXIMATELY A 45 DEGREE ANGLE, POSSIBLY DUE TO FORCES APPLIED DURING USE. THE PEN NEEDLE WAS ATTACHED TO A TEST PEN. SALINE WAS PUSHED THROUGH THE TEST PEN AND OUT THE DISTAL TIP OF THE CANNULA WITHOUT ISSUE. NO CLOG FOUND BUT PEN NEEDLE WAS BENT DURING USE. 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. BASED ON THE SAMPLE RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF BENDING DURING USE. THE ROOT CAUSE OF THE PATIENT END OF THE CANNULA BENDING DURING USE IS MOST LIKELY DUE TO STRESSES PLACED ACROSS THE LENGTH OF THE CANNULA DURING USE. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO 2ND GEN PEN NEEDLE THAT THERE IS NO INSULIN FLOW WHEN TAKING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, NO INSULIN FLOW WHEN TAKING INJECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO 2ND GEN PEN NEEDLE THAT THERE IS NO INSULIN FLOW WHEN TAKING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, NO INSULIN FLOW WHEN TAKING INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207510 BD NANO 2ND GEN PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON AND CO. 320550 1132267 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown