BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 9983768 · Received April 21, 2020

    Report

    Report Number
    9616656-2020-00342
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    April 10, 2020
    Report Date
    April 13, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    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 · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A SHELF CARTON OF 4MM, 32G PEN NEEDLES FROM LOT # 9232984, NO SAMPLES (INCLUDING PHOTOS OF THE SAMPLES IN QUESTION) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS OF THE SAMPLES IN QUESTION WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS OF THE SAMPLES IN QUESTION WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE ISSUE OCCURRED DURING USE WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER CALLED IN AND CONFIRMED VERBATIM IN EMAIL. STATED, NEEDLE BENT AT PATIENT END WHEN TRYING TO ADMINISTER HER DAUGHTERS INSULIN AND A SECOND TIME, NEEDLE FELL OUT FROM HUB WHEN TRYING TO ADMINISTER SHOT. BOTH INCIDENTS HAPPENED ON THE SAME DAY. STATED, WAS ABLE TO GIVE HER DAUGHTER THE SHOT, THE THIRD TIME AROUND. VERBATIM FROM EMAIL BELOW: MY DAUGHTER HAS TYPE 1 DIABETES AND WE WERE PRESCRIBED BD NANO ULTRA-FINE PEN NEEDLES TO USE WITH HER INSULIN PENS. WE HAVE HAD TWO DEFECTIVE NEEDLES IN THE CURRENT BOX. ONE NEEDLE HAD A BENT TIP AND WE DIDN'T NOTICE UNTIL WE FOUND IT VERY DIFFICULT TO ADMINISTER THE SHOT. ON THE OTHER DEFECTIVE NEEDLE; THE NEEDLE JUST FELL OUT OF THE BASE WHEN WE PRIMED IT. I AM JUST REPORTING THIS FOR YOUR QUALITY CONTROL DATA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443898 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 9232984 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other