BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO PEN NEEDLE WITH PENTAPOINT¿ COMFORT EASYFLOW¿ TECHNOLOGY

    MDR report key: 15676409 · Received October 26, 2022

    Report

    Report Number
    9616656-2022-01148
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    October 3, 2022
    Report Date
    December 19, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903204892
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: CUSTOMER RETURNED SEVERAL IMAGES OF THE 32GX4MM NANO PEN NEEDLE FROM LOT 2012557. NO PHYSICAL SAMPLE WAS RETURNED; THEREFORE, THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. THE CONSUMER REPORTED CLOGGED NEEDLES. THE IMAGES WERE OBSERVED, PHOTOS #1 AND #2 ARE PICTURES OF THE BACK OF A BOX REVEALING THE LOT NUMBER AND PHOTO #3 SHOWS THREE SODA BOTTLES FULL OF USED PEN NEEDLES. BASED ON THE PHOTOS ALONE, THERE¿S NO SUFFICIENT EVIDENCE TO CONFIRM GLUCOSE LEVEL. 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. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1195490. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2026. DEVICE MANUFACTURE DATE: 14-JUL-2021. MEDICAL DEVICE LOT #: 1173062. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026. DEVICE MANUFACTURE DATE: 22-JUN-2021. MEDICAL DEVICE LOT #: 1110188. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2026. DEVICE MANUFACTURE DATE: 20-APR-2021. MEDICAL DEVICE LOT #: 2005371. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027. DEVICE MANUFACTURE DATE: 05-JAN-2022. MEDICAL DEVICE LOT #: 2012557. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027. DEVICE MANUFACTURE DATE: 12-JAN-2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD ULTRA-FINE¿ NANO PEN NEEDLE WITH PENTAPOINT¿ COMFORT EASYFLOW¿ TECHNOLOGY WAS CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "CLOGGED NEEDLES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD ULTRA-FINE¿ NANO PEN NEEDLE WITH PENTAPOINT¿ COMFORT EASYFLOW¿ TECHNOLOGY WAS CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "CLOGGED NEEDLES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2599697 BD ULTRA-FINE¿ NANO PEN NEEDLE WITH PENTAPOINT¿ COMFORT EASYFLOW¿ TECHNOLOGY HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H10 00382903204892

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown