BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE

    MDR report key: 16903474 · Received May 10, 2023

    Report

    Report Number
    9616656-2023-00464
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    April 17, 2023
    Report Date
    June 8, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 21APR2023. H6: INVESTIGATION SUMMARY . A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 2091874 FOR GLUCOSE LEVEL. THIS IS THE 1ST. RELATED COMPLAINT FOR GLUCOSE LEVEL ON LOT # 2091874. INVESTIGATION SUMMARY: CUSTOMER RETURNED (62) UNOPENED PEN NEEDLE AUTOSHIELD DUO IN A SHELF CARTON FROM LOT# 2091874.IT WAS NOTICED ON SEVERAL USES THAT THERE WAS INSULIN RESIDUE LEFT IN THE NEEDLE AFTER ADMINISTERING TO THE PATIENT. ALL THE RETURNED SAMPLES WERE VISUALLY EXAMINED AND OBSERVED NO DAMAGES. FUNCTIONALITY TEST WAS PERFORMED ON 30 PEN NEEDLES AND OBSERVED PROPER FLOW OF SALINE THROUGH THE CANNULA WITHOUT ANY ISSUES. NO ISSUES TO THE NEEDLES OF ANY KIND WAS OBSERVED AND ALL FUNCTIONED AS INTENDED. HENCE, THE ALLEGED ISSUE COULD NOT BE CONFIRMED. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. UNCONFIRMED: BASED ON THE SAMPLE RECEIVED, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AS THE ISSUE IS UNCONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD AUTOSHIELD¿ DUO PEN NEEDLE WAS DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS NOTICED ON SEVERAL USES THAT THERE WAS INSULIN RESIDUE LEFT IN THE NEEDLE AFTER ADMINISTERING TO THE PATIENT. THIS MEANT THE PATIENT WAS NOT GETTING THE FULL DOSE OF INSULIN ON EACH OCCASION. DIFFERENT NURSES TRIED WITH SAME RESULTS TO RULE OUT INDIVIDUAL TECHNIQUE. THE PATIENT'S BLOOD GLUCOSE STARTED TO BECOME ERRATIC AFTER BEING STABLE FOR SOME TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD AUTOSHIELD¿ DUO PEN NEEDLE WAS DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS NOTICED ON SEVERAL USES THAT THERE WAS INSULIN RESIDUE LEFT IN THE NEEDLE AFTER ADMINISTERING TO THE PATIENT. THIS MEANT THE PATIENT WAS NOT GETTING THE FULL DOSE OF INSULIN ON EACH OCCASION. DIFFERENT NURSES TRIED WITH SAME RESULTS TO RULE OUT INDIVIDUAL TECHNIQUE. THE PATIENT'S BLOOD GLUCOSE STARTED TO BECOME ERRATIC AFTER BEING STABLE FOR SOME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579231 BD AUTOSHIELD¿ DUO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2091874

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other