BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT)

    MDR report key: 17432976 · Received August 1, 2023

    Report

    Report Number
    9616656-2023-00802
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 2, 2023
    Report Date
    August 3, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903295159
    PMA / PMN Number
    K223286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    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. 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT) THERE WAS LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT WAS FORWARDED TO DIABETES ON 7/7/2023 BUT CONSUMER CALLED IN TODAY TO ALSO REPORT THE ISSUE. FOLLOW UP ON FILE CS0067342. AWARENESS DATE WAS CHANGED TO 7/7/2023. PLEASE NOTE CONSUMER ALSO REPORTED ISSUE HAPPENING ON 7/2/2023. "MATERIAL NUMBER: 329515 LOT/BATCH NUMBER: 3010164 CALLER WAS INSTRUCTED BY HER ENDOCRINOLOGIST TO REPORT CONSISTENTLY HIGH BLOOD SUGAR LEVELS FOLLOWING INSULING INJECTIONS USING THE AUOTSHIELD DUO, AS SHE HAS NOT EXPERIENCED THIS ISSUE WHEN USING OTHER SIMILAR PRODUCTS. SHE BEGAN USING THIS PRODUCT ON 7/2/2023 AND HAS HAD 10 OCCURRENCES OF ABNORMALLY HIGH BGL POST INJECTION, CONTRIBUTING TO PERSISTENT INSOMNIA AND NAUSEA." CONSUMER REPORTED WHEN TAKING INJECTION, THERE IS LEAKAGE ON THE INJECTION SITE STATED, THE INSULIN IS NOT GOING INTO INJECTION SITE STATED, HER BLOOD SUGAR HAS BEEN IN THE FIVE HUNDREDS AND SHE WENT TO THE EMERGENCY ROOM WHEN ASKED IF HOSPITAL OR DOCTOR WAS ABLE TO GET HER NUMBERS UNDER CONTROL BY GIVING HER A SHOT WHEN SHE WAS THERE, CONSUMER STATED, "NO". STATED SHE DID NOT GET HER INSULIN IN THE EMERGENCY ROOM BUT WENT HOME INSTEAD AND TRIED TO TAKE HER INJECTION AGAIN. LOT: 3010164 CATALOG: 329515 DATE OF EVENT: (B)(6) 2023 SAMPLES: NO CL.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT) THERE WAS LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT WAS FORWARDED TO DIABETES ON (B)(6) 2023 BUT CONSUMER CALLED IN TODAY TO ALSO REPORT THE ISSUE. FOLLOW UP ON FILE (B)(4). AWARENESS DATE WAS CHANGED TO (B)(6) 2023. PLEASE NOTE CONSUMER ALSO REPORTED ISSUE HAPPENING ON (B)(6) 2023. "MATERIAL NUMBER: 329515. LOT/BATCH NUMBER: 3010164. CALLER WAS INSTRUCTED BY HER ENDOCRINOLOGIST TO REPORT CONSISTENTLY HIGH BLOOD SUGAR LEVELS FOLLOWING INSULING INJECTIONS USING THE AUOTSHIELD DUO, AS SHE HAS NOT EXPERIENCED THIS ISSUE WHEN USING OTHER SIMILAR PRODUCTS. SHE BEGAN USING THIS PRODUCT ON (B)(6) 2023 AND HAS HAD 10 OCCURRENCES OF ABNORMALLY HIGH BGL POST INJECTION, CONTRIBUTING TO PERSISTENT INSOMNIA AND NAUSEA." CONSUMER REPORTED WHEN TAKING INJECTION, THERE IS LEAKAGE ON THE INJECTION SITE STATED, THE INSULIN IS NOT GOING INTO INJECTION SITE STATED, HER BLOOD SUGAR HAS BEEN IN THE FIVE HUNDREDS AND SHE WENT TO THE EMERGENCY ROOM WHEN ASKED IF HOSPITAL OR DOCTOR WAS ABLE TO GET HER NUMBERS UNDER CONTROL BY GIVING HER A SHOT WHEN SHE WAS THERE, CONSUMER STATED, "NO". STATED SHE DID NOT GET HER INSULIN IN THE EMERGENCY ROOM BUT WENT HOME INSTEAD AND TRIED TO TAKE HER INJECTION AGAIN. LOT: 3010164. CATALOG: 329515. DATE OF EVENT: (B)(6) 2023. SAMPLES: NO CL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338561 BD AUTOSHIELD¿ DUO PEN NEEDLE 30G X 5MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3010164 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown