BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 9603306 · Received January 17, 2020

    Report

    Report Number
    9616657-2020-00009
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Date of Event
    January 13, 2020
    Report Date
    January 14, 2020
    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
    NJ, US
    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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9081756, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-05-17. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: LEVEL B 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 4TH RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 9081756. UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK DUE TO AN UNKNOWN LOT NUMBER FOR NEEDLE CLOG. 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 ULTRA FINE¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN DURING USE. THIS OCCURRED ON 10 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122, BATCH NO: (B)(4), UNKNOWN. IT WAS REPORTED INSULIN IS NOT COMING OUT DURING INJECTION. INSULIN IS NOT GETTING DISPENSED DURING THE INJECTION HAS OCCURRED IN THE PAST WITH OTHER 3-4 BOXES. VERBATIM: ISSUE: CONSUMER REPORTED INSULIN IS NOT COMING OUT DURING INJECTION. ISSUE: INSULIN IS NOT GETTING DISPENSED DURING THE INJECTION HAS OCCURRED IN THE PAST WITH OTHER 3-4 BOXES. ALL COMBINING ABOUT BOX OF NEEDLES DID NOT WORK. CONSUMER USES THE NEW NEEDLE EACH TIME OF HIS INJECTION. HE DOES NOT VISUALLY TEST THE NEEDLE TO SEE STRAIGHT, BUT STATED THEY WERE ALL STRAIGHT. EXPLAINED THE REASON WHY TO VISUALLY TEST. HE USES THE LEVAMIR, HE DID NOT ANSWER REGARDING HOW HE ATTACHES THE PEN NEEDLE ON TO THE PEN. EXPLAINED ABOUT ATTACHING THE NEEDLE FIRMLY ON TO THE PEN. ADVISED TO SAVE THE SAMPLE IF RE OCCURS. OFFERED TO SEND THE VOUCHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66996 BD ULTRA FINE PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. SEE H.10 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other