BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ INSULIN PEN NEEDLE

    MDR report key: 9495595 · Received December 19, 2019

    Report

    Report Number
    9616656-2019-01254
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Date of Event
    December 5, 2019
    Report Date
    January 13, 2020
    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
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION. - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR BREAKS OFF DURING USE ON LOT # 8233917 INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 4MM, 32G PEN NEEDLES WITH THE SHELF CARTON FROM LOT # 8233917. CUSTOMER STATES THAT THE METAL OF THE NEEDLE GETS OUT OF THE PLASTIC. THE PHOTOS WERE EXAMINED AND EXHIBITED THE ENTIRE CANNULA SEPARATED FROM THE HUB. MANUFACTURING (IRELAND) WILL BE NOTIFIED OF THIS ISSUE. 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: 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 (CANNULA SEPARATES) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA FINE¿ INSULIN PEN NEEDLE CANNULA BREAKS OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS: IT HAPPENED TWO TIMES - THE METAL OF THE NEEDLE GETS OUT OF PLASTIC, BOTH TIMES, I GOT SCARED A LOT, I THOUGHT IT HAD STAYED INSIDE THE BODY, UNTIL I SEE THAT IS IN THE PENS (THIS HAPPENS WHEN I EXCHANGE THE NEEDLE OF A PEN TO ANOTHER).

    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_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK COULD NOT BE PERFORMED FOR THE DEFECT/CONDITION REPORTED SINCE THE LOT NUMBER WAS NOT PROVIDED. 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. DHR COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES / PHOTO(S) 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 ULTRA FINE¿ INSULIN PEN NEEDLE CANNULA BREAKS OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS: IT HAPPENED TWO TIMES - THE METAL OF THE NEEDLE GETS OUT OF PLASTIC, BOTH TIMES, I GOT SCARED A LOT, I THOUGHT IT HAD STAYED INSIDE THE BODY, UNTIL I SEE THAT IS IN THE PENS (THIS HAPPENS WHEN I EXCHANGE THE NEEDLE OF A PEN TO ANOTHER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294655 BD ULTRA FINE¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8233917

    Patients

    Seq Age Sex Outcome Treatment
    1 Other