BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NDL 32G 4MM PRO

    MDR report key: 12543737 · Received September 28, 2021

    Report

    Report Number
    9616656-2021-01205
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 30, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-10-08. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED 5 UNOPENED 4MM, 32 GAUGE NANO PRO PEN NEEDLES FROM LOT 1012829. THE PEN NEEDLE IN QUESTION WAS NOT RETURNED FOR INVESTIGATION. EACH OF THE RETURNED PEN NEEDLES WERE INSPECTED AND FOUND TO BE IN GOOD CONDITION. THESE PEN NEEDLES WERE ATTACHED TO A TEST PEN AND THEN INSERTED INTO A SKIN ANALOG. ALL OF THE PEN NEEDLES WERE INTACT AFTER SIMULATED USE TESTING. SALINE WAS PUSHED THROUGH THE SYSTEM AND OUT THE DISTAL TIP OF EACH OF THE PEN NEEDLES. AS PRESSURE EQUALIZED IN THE SYSTEM, SALINE STOPPED EXITING FROM THE PEN NEEDLE. NO LEAKS WERE OBSERVED. THE PEN NEEDLES RETURNED WERE UNDAMAGED AND FUNCTIONED AS INTENDED. 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. BASED ON THE SAMPLES RECEIVED, BD WAS UNABLE TO REPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE PEN NEEDLES LEAKING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD PEN NDL 32G 4MM PRO LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THE NEEDLE BENDS DURING INJECTION WITH THE INSULIN LEAKING OUT AND DOWN THE CONSUMERS' ARM. DATE OF EVENT : UNKNOWN. SAMPLE STATUS : AWAITING SAMPLE.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT 1 BD PEN NDL 32G 4MM PRO LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THE NEEDLE BENDS DURING INJECTION WITH THE INSULIN LEAKING OUT AND DOWN THE CONSUMERS' ARM. DATE OF EVENT : UNKNOWN. SAMPLE STATUS : AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439899 BD PEN NDL 32G 4MM PRO HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 1012829 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1