BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 9564762 · Received January 8, 2020

    Report

    Report Number
    9616657-2019-00400
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    December 24, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED TWO (2) USED 32GX4MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. CONSUMER REPORTED INSULIN DID NOT FLOW DURING INJECTION; STATED, HAS BRUISING AS A RESULT OF PUSHING TOO HARD TO GET INSULIN TO FLOW. BOTH RETURNED PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT ONE EXHIBITED A BENT NON-PATIENT END (NPE) CANNULA, AND THE OTHER EXHIBITED A BROKEN NPE CANNULA. BOTH PEN NEEDLES WERE TESTED FOR VISUAL INSPECTION OF POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE.IT WAS OBSERVED THAT ONE OF TESTED PEN NEEDLES EXHIBITED A HOOKED PATIENT END (PE) CANNULA POINT. NO EVIDENCE OF MANUFACTURING DEFECTS WERE OBSERVED ON THE RETURNED SAMPLES. THE BENT AND 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 BOTH OF THE PEN NEEDLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT NPE CANNULA, BROKEN NPE CANNULA, AND HOOKED PE CANNULA POINT IS USER ERROR WHEN USING THE PEN NEEDLES. USER ERROR WHEN ATTACHING A PEN NEEDLE TO A PEN INJECTOR MAY RESULT IN A BENT OR BROKEN NPE CANNULA. USER ERROR WHEN REMOVING THE CANNULA SHIELD, OR USER ERROR DURING INJECTION MAY RESULT IN A HOOKED PE CANNULA. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES WOULD NOT ALLOW INSULIN TO FLOW. THIS OCCURRED ON 3 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122 BATCH NO. 9113866 IT WAS REPORTED THAT INSULIN DID NOT FLOW DURING INJECTION AND HAD BRUISING FROM PUSHING HARD TO TRY TO GET THE INSULIN TO FLOW. VERBATIM: CONSUMER REPORTED INSULIN DID NOT FLOW DURING INJECTION. CANNOT REMEMBER IF HE PRIMED FIRST. STATED, HAS BRUISING AS A RESULT OF PUSHING TOO HARD TO GET INSULIN TO FLOW. DID NOT SEEK MEDICAL FOR BRUISING. 3 PEN NEEDLES AFFECTED ON SAME DAY BUT HE COULD NOT REMEMBER THE DATE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES WOULD NOT ALLOW INSULIN TO FLOW. THIS OCCURRED ON 3 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122 BATCH NO. 9113866. IT WAS REPORTED THAT INSULIN DID NOT FLOW DURING INJECTION AND HAD BRUISING FROM PUSHING HARD TO TRY TO GET THE INSULIN TO FLOW. VERBATIM: CONSUMER REPORTED INSULIN DID NOT FLOW DURING INJECTION. CANNOT REMEMBER IF HE PRIMED FIRST. STATED, HAS BRUISING AS A RESULT OF PUSHING TOO HARD TO GET INSULIN TO FLOW. DID NOT SEEK MEDICAL FOR BRUISING. 3 PEN NEEDLES AFFECTED ON SAME DAY BUT HE COULD NOT REMEMBER THE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30045 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 2865 9113866 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other