BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 9451063 · Received December 11, 2019

    Report

    Report Number
    9616656-2019-01227
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 25, 2019
    Report Date
    November 27, 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
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9141563 MEDICAL DEVICE EXPIRATION DATE: 2024-05-31 DEVICE MANUFACTURE DATE: 2019-05-21 MEDICAL DEVICE LOT #: UNKNOWN MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: UNKNOWN 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 2ND RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 9141563. INVESTIGATION SUMMARY: NO SAMPLES 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 CONFORMANCE'S 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 / 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¿ PEN NEEDLES WERE NOT ABLE TO DISPENSE INSULIN DURING INJECTION. THIS OCCURRED ON 40 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 BATCH NO: 9141563, UNKNOWN. IT WAS REPORTED THAT INSULIN IS NOT GETTING DISPENSED DURING THE INJECTION AND DURING THE PRIMING. VERBATIM: ISSUE: INSULIN IS NOT GETTING DISPENSED DURING THE INJECTION AND DURING THE PRIMING. IT HAPPENED ABOUT 40 TIMES WITH THIS BOX. SAMPLE DISCARDED. ISSUE: INSULIN DID NOT GET DISPENSED DURING THE INJECTION AND DURING THE FLOW CHECK IN THE PAST. SAMPLE DISCARDED. CONSUMER USES THE NEW NEEDLE EACH TIME OF HER INJECTION. SHE VISUALLY TEST THE NEEDLE TO SEE IF IT IS STRAIGHT. SHE TURNS THE NEEDLE IT GET GETS TIGHT DURING ATTACHMENT. SHE ROTATE THE INJECTION SITE. ADVISED CONSUMER TO SAVE THE SAMPLE IF RE OCCURS, OFFERED TO SEND THE VOUCHER. ALSO, ADVISED CONSUMER SINCE THERE ARE MORE OCCURENCE, TO GO OVER THE INSTRUCTION WITH THE DOCTOR ON HER NEXT VISIT TO THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250049 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