BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLE

    MDR report key: 9008443 · Received September 12, 2019

    Report

    Report Number
    9616656-2019-00859
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Date of Event
    August 26, 2019
    Report Date
    September 20, 2019
    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: INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A SHELF CARTON OF 4MM, 32G PEN NEEDLES FROM LOT # 9022892. CUSTOMER STATES THAT THE NEEDLES CLOG OR JUST DON'T WORK. THE PHOTOS WERE EXAMINED AND ONLY THE SHELF CARTON WAS SHOWN IN THE PHOTOS. IT IS DIFFICULT TO DETERMINE IF THERE IS A CLOG OR OTHER DEFECT IN THE PEN NEEDLES SOLELY FROM THE PHOTOS. 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: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS IT IS DIFFICULT TO DETERMINE IF THERE IS A CLOG OR OTHER DEFECT IN THE PEN NEEDLES SOLELY FROM THE ATTACHED PHOTOS 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 INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    MATERIAL NO: 320122, BATCH NO: 9022892. IT WAS REPORTED THAT DURING USE OF THE BD ULTRA FINE¿ PEN NEEDLE THE CUSTOMER ENCOUNTERED NEEDLES CLOG OR JUST NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY FRIEND HAS DIABETES AND USES BD'S NANO ULTRA-FINE PEN NEEDLES PRODUCT. I NOTICED A BD BOX AT HIS PLACE AND ASKED HIM ABOUT THE PRODUCT. HE SAID HE WAS VERY DISSATISFIED WITH THE PRODUCT, THE PROBLEM IS THE NEEDLES CLOG OR JUST DON'T WORK. IT IS A HIGH PERCENTAGE, ANYWHERE FROM 7 TO 10 NEEDLES PER BOX OF 100. THIS MORNING I GOT AN EMAIL FROM HIM WITH MORE BAD NEWS. HE SAID "4 OF 6 NEEDLES THAT I PUT INTO MY PEN WERE DUDS/BLOCKED. THIS HAPPENS TO FREQUENTLY."

    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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED

    Description of Event or Problem · 1

    MATERIAL NO: 320122 BATCH NO: 9022892 IT WAS REPORTED THAT DURING USE OF THE BD ULTRA FINE¿ PEN NEEDLE THE CUSTOMER ENCOUNTERED NEEDLES CLOG OR JUST NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY FRIEND HAS DIABETES AND USES BD'S NANO ULTRA-FINE PEN NEEDLES PRODUCT. I NOTICED A BD BOX AT HIS PLACE AND ASKED HIM ABOUT THE PRODUCT. HE SAID HE WAS VERY DISSATISFIED WITH THE PRODUCT, THE PROBLEM IS THE NEEDLES CLOG OR JUST DON'T WORK. IT IS A HIGH PERCENTAGE, ANYWHERE FROM 7 TO 10 NEEDLES PER BOX OF 100. THIS MORNING I GOT AN EMAIL FROM HIM WITH MORE BAD NEWS. HE SAID "4 OF 6 NEEDLES THAT I PUT INTO MY PEN WERE DUDS/BLOCKED. THIS HAPPENS TO FREQUENTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799592 BD ULTRA FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9022892 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other