BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLE

    MDR report key: 8859966 · Received August 5, 2019

    Report

    Report Number
    9616656-2019-00703
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    July 20, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403897511
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (25) USED 32GX4MM BD PEN NEEDLES: 16 FROM LOT 9092812, 5 FROM LOT 8304794, 3 FROM LOT 8304793, 1 FROM LOT 8072769. CUSTOMER REPORTED NO INSULIN FLOW WHEN PRIMING. ALL 25 RETURNED PEN NEEDLES WERE EXAMINED, AND THE FOLLOWING WAS OBSERVED: - FROM LOT 9092812, 9 WITH BROKEN NON-PATIENT END (NPE) CANNULAS AND 7 WITH BENT NPE CANNULA. - FROM LOT 8304794, 4 WITH BROKEN NPE CANNULAS AND 1 WITH A BENT NPE CANNULA. - FROM LOT 8304793, 3 WITH BROKEN NPE CANNULAS. - FROM LOT 8072769, 1 WITH A BROKEN NPE CANNULA. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THE RETURNED SAMPLES. THE BENT OR BROKEN NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED (AS REPORTED). SINCE ALL 25 PEN NEEDLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT OR BROKEN NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLES HAD NO INSULIN FLOW DURING USE WHILE PRIMING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I BECAME VERY FRUSTRATED WITH THIS PAK OF NEEDLES. IT SEEMED LIKE 50% OF THEM WERE STOPPED UP AND WOULD NOT LET INSULIN THRU NEEDLE." STATED: NO INSULIN FLOW WHEN PRIMING. STATED: TWO PEN NEEDLES AFFECTED ON THE DAY HE SENT THE EMAIL, ((B)(6) 2019)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLES HAD NO INSULIN FLOW DURING USE WHILE PRIMING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I BECAME VERY FRUSTRATED WITH THIS PAK OF NEEDLES. IT SEEMED LIKE 50% OF THEM WERE STOPPED UP AND WOULD NOT LET INSULIN THRU NEEDLE." STATED: NO INSULIN FLOW WHEN PRIMING. STATED: TWO PEN NEEDLES AFFECTED ON THE DAY HE SENT THE EMAIL, (07/20/19)

    Additional Manufacturer Narrative · 1

    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 2 BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLES HAD NO INSULIN FLOW DURING USE WHILE PRIMING. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I BECAME VERY FRUSTRATED WITH THIS PAK OF NEEDLES. IT SEEMED LIKE 50% OF THEM WERE STOPPED UP AND WOULD NOT LET INSULIN THRU NEEDLE." STATED: NO INSULIN FLOW WHEN PRIMING. STATED: TWO PEN NEEDLES AFFECTED ON THE DAY HE SENT THE EMAIL, ((B)(6) 2019).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656852 BD ULTRA-FINE¿ NANO INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8304793 10885403897511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other