BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 8983351 · Received September 10, 2019

    Report

    Report Number
    9616656-2019-00848
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 19, 2019
    Report Date
    September 20, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403801518
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR CLOG ON LOT # 9022886. INVESTIGATION SUMMARY: CUSTOMER RETURNED TEN (10) USED 31G X 8MM BD PEN NEEDLES WITHOUT TEAR DROP LABELS ATTACHED. CONSUMER REPORTED NO INSULIN FLOW DURING PRIMING. ALL 10 RETURNED SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT NINE SAMPLES HAD BENT NON-PATIENT END (NPE) CANNULAS, AND ONE SAMPLE HAD A BROKEN NPE CANNULA, HOWEVER, NO MANUFACTURING DEFECTS WERE OBSERVED ON THE SAMPLES (SEE ATTACHED PHOTOS). AS ALL 10 SAMPLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT AND BROKEN NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. 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). 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. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT AND BROKEN NPE CANNULAS) COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME H3 OTHER TEXT : SEE H. 10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO INSULIN FLOW OCCURRED DURING USE WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED 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 THAT NO INSULIN FLOW OCCURRED DURING USE WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED NO INSULIN FLOW DURING PRIMING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778688 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9022886 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Other