BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO PRO¿ 4MM PEN NEEDLE

    MDR report key: 9134589 · Received September 30, 2019

    Report

    Report Number
    9616656-2019-00922
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    September 16, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: 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 NEEDLE PAIN & NEEDLE CLOG ON LOT # 9072616. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED 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. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD NANO PRO¿ 4MM PEN NEEDLE WAS UNABLE TO DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 320555, BATCH NO.: 9072616. IT WAS REPORTED THAT THE CONSUMER EXPERIENCED PAIN DURING INJECTION AND THAT THE PEN NEEDLE DOES NOT DISPENSE THE INSULIN CAUSING HIM TO SOMETIMES SEE A BUBBLE. CONSUMER REPORTED PAIN DURING INJECTION EVERY SINCE HE HAS STARTED USING THE NANO PRO SINCE 3 MONTHS, HE USES 4 TIMES A DAY. PEN NEEDLE DOES NOT DISPENSE THE INSULIN SOMETIMES HE SEES BUBBLE. IT HAPPENS EVERY OTHER DAY. SAMPLE DISCARDED. HE USES THE NEW PEN NEEDLE EACH TIME OF HIS INJECTION. HE DOES THE PRIMING. HE ROTATES THE INJECTION SITE. HE VISUALLY TESTS THE NEEDLE TO SEE IF IT IS STRAIGHT. HE FIRMLY ATTACHES THE PEN NEEDLE ON TO THE PEN. READ PRIVACY STATEMENT, CONSUMER REFUSED TO PROVIDE PERSONAL INFORMATION. HE REFUSED TO GET A REPLACEMENT OF THE PRODUCT. ADVISED CONSUMER TO SAVE THE SAMPLE IF RE OCCURENCE. CONSUMER ALSO STATED DRUG MART HAS TOLD HIM THE NANO NEEDLE HAS BEEN DISCONTINUED. EXPLAINED CONSUMER WE ARE STILL MANUFACTURING THOSE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931689 BD NANO PRO¿ 4MM PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 9072616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other