BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 9439817 · Received December 9, 2019

    Report

    Report Number
    9616656-2019-01218
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 20, 2019
    Report Date
    November 25, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9099930 MEDICAL DEVICE EXPIRATION DATE: 2024-04-30 DEVICE MANUFACTURE DATE: 2019-04-09 MEDICAL DEVICE LOT #: 9113867 MEDICAL DEVICE EXPIRATION DATE: 2024-05-31 DEVICE MANUFACTURE DATE: 2019-06-11 INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) 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'S WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION 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

    MATERIAL NO.: 320122 BATCH NO.: 9099930, 9113867. IT WAS REPORTED THAT DURING THE USE OF THE BD ULTRA FINE¿ PEN NEEDLES THE PEN NEEDLES STOP DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER IS FINDING PEN NEEDLES ON BOTH PENS STOP DURING INJECTION. CONSUMER STATED HE SHOWED HIS PHARMACIST NEEDLE CLOGGED ON PEN. PHARMACY REMOVED CLOGGED PEN NEEDLE AND REPLACED WITH NEW PEN NEEDLE. THE NEW PEN NEEDLE WORKED FOR THIS CONSUMERS INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237279 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other