BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 11810515 · Received May 12, 2021

    Report

    Report Number
    9616656-2021-00511
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 13, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) OPEN 4MM, 32G PEN NEEDLES (1 WITHOUT THE TEAR DROP LABEL) FROM LOT # 0203824. CUSTOMER STATES THAT THE NEEDLE CLOGGED DURING INJECTION. BOTH RETURNED PEN NEEDLES WERE EXAMINED AND ONE EXHIBITED A BENT NON PATIENT END OF THE CANNULA. THE REMAINING SAMPLE EXHIBITED A BROKEN NON PATIENT END OF THE CANNULA. 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. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE IS USER RELATED. THE BENT AND BROKEN NON PATIENT END OF THE CANNULA OCCURRED DURING USE OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD ULTRA FINE¿ PEN NEEDLE 4MM X 32G WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : MATERIAL NO. 320550; BATCH NO. 0203824. IT WAS REPORTED THAT THE NEEDLE CLOGGED DURING INJECTION AND THAT THERE IS NO INSULIN FLOW. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE: SENDING MAIL KIT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS PENDING 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 ULTRA FINE¿ PEN NEEDLE 4MM X 32G WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : MATERIAL NO. 320550, BATCH NO. 0203824. IT WAS REPORTED THAT THE NEEDLE CLOGGED DURING INJECTION AND THAT THERE IS NO INSULIN FLOW. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710044 BD ULTRA FINE PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 0203824 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1