BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 9876069 · Received March 24, 2020

    Report

    Report Number
    9616656-2020-00259
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    February 23, 2020
    Report Date
    March 26, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES OR PHOTOS WERE RETURNED FOR ANALYSIS. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE WAS RESISTANT AND DID NOT DELIVER INSULIN DURING USE. THE PRODUCT WAS USED ON A PATIENT WITH A BLOOD SUGAR LEVEL OF "2.09" TO DELIVER "10UI OF NOVORAPID". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ENTRANCE IN ROOM TO GIVE HIM 10UI OF NOVORAPID INSULIN FOR A BLOOD SUGAR LEVEL OF 2.09 IN A PATIENT WITH AN IMBALANCE ON SYNDROME INFECTIOUS. AFTER THE PATIENT IS PRICKED, WHEN INJECTING THE PRODUCT, THE INSULIN PEN WHEEL FOR PUSHING THE PRODUCT DOES NOT RELEASE, PRESENTED A RESISTANCE. NEEDLE WITHDRAWN, NO DROP OF INSULIN ON THE PATIENT'S ARM OR OUT OF THE NEEDLE. AT THE TIME OF NEEDLE MISADAPTATION SECURED, THE NEEDLE IS NOT STUCK IN THE OPERCULUM OF THE STYLE AND THE BASE IS BULGING. NEEDLE THROWN: LOT 9231942 HE DID NOT GET HIS INSULIN DOSE, NEEDLE WAS CHANGED AND DOSE ADMINISTERED. "POSSIBILITY OF INSULIN OVERDOSE OR UNDERDOSE IF THE AMOUNT ACTUALLY ADMINISTERED DESPITE THE FACT THAT THE NEEDLE WAS NOT STUCK IN THE OPERCULUM. IF HYPOGLYCEMIA, RISK OF COMA, IF HYPERGLYCEMIA, RISK OF ACID KETOTIC COMA. BLOOD GLUCOSE MONITORING AT THE MEAL STATION, BUT PATIENT WENT DOWN TO THE CAFETERIA."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE WAS RESISTANT AND DID NOT DELIVER INSULIN DURING USE. THE PRODUCT WAS USED ON A PATIENT WITH A BLOOD SUGAR LEVEL OF "2.09" TO DELIVER "10UI OF NOVORAPID". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ENTRANCE IN ROOM TO GIVE HIM 10UI OF NOVORAPID INSULIN FOR A BLOOD SUGAR LEVEL OF 2.09 IN A PATIENT WITH AN IMBALANCE ON SYNDROME INFECTIOUS. AFTER THE PATIENT IS PRICKED, WHEN INJECTING THE PRODUCT, THE INSULIN PEN WHEEL FOR PUSHING THE PRODUCT DOES NOT RELEASE, PRESENTED A RESISTANCE. NEEDLE WITHDRAWN, NO DROP OF INSULIN ON THE PATIENT'S ARM OR OUT OF THE NEEDLE. AT THE TIME OF NEEDLE MISADAPTATION SECURED, THE NEEDLE IS NOT STUCK IN THE OPERCULUM OF THE STYLE AND THE BASE IS BULGING. NEEDLE THROWN: LOT 9231942. HE DID NOT GET HIS INSULIN DOSE, NEEDLE WAS CHANGED AND DOSE ADMINISTERED. "POSSIBILITY OF INSULIN OVERDOSE OR UNDERDOSE IF THE AMOUNT ACTUALLY ADMINISTERED DESPITE THE FACT THAT THE NEEDLE WAS NOT STUCK IN THE OPERCULUM. IF HYPOGLYCEMIA, RISK OF COMA, IF HYPERGLYCEMIA, RISK OF ACID KETOTIC COMA. BLOOD GLUCOSE MONITORING AT THE MEAL STATION, BUT PATIENT WENT DOWN TO THE CAFETERIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339538 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9231942

    Patients

    Seq Age Sex Outcome Treatment
    1 Other