BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD AUTOSHIELD¿ DUO

    MDR report key: 17808028 · Received September 25, 2023

    Report

    Report Number
    9616656-2023-01029
    Event Type
    Injury
    Date Received
    September 25, 2023
    Date of Event
    September 8, 2023
    Report Date
    October 19, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FMI
    UDI-DI
    00382903296057
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.6 INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO THE MEDICATION COULD NOT BE PROPERLY DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WITH THE NEEDLES BATCH: 3069581 THE ADMINISTRATION OF THE PRODUCT WAS PARTIAL (THE BLOOD SUGAR INCREASED) BECAUSE: BY CHANGING THE DEVICE BATCH: 0316753 AND 2060479 AT AN EQUAL DOSE THE PRODUCT WAS MORE ACTIVE THE DEXTRO DECREASED A LOT, THE NURSE WAS EVEN ABLE TO REDUCE THE INSULIN PROTOCOL TO DATE (REDUCED DOSES OF INSULIN).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO THE MEDICATION COULD NOT BE PROPERLY DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WITH THE NEEDLES BATCH: 3069581 THE ADMINISTRATION OF THE PRODUCT WAS PARTIAL (THE BLOOD SUGAR INCREASED) BECAUSE: BY CHANGING THE DEVICE BATCH: 0316753 AND 2060479 AT AN EQUAL DOSE THE PRODUCT WAS MORE ACTIVE THE DEXTRO DECREASED A LOT, THE NURSE WAS EVEN ABLE TO REDUCE THE INSULIN PROTOCOL TO DATE (REDUCED DOSES OF INSULIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295089 BD AUTOSHIELD¿ DUO HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3069581 00382903296057

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention