BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PN 32G 4MM 5B XTW EASYFLOW LA

    MDR report key: 11032780 · Received December 17, 2020

    Report

    Report Number
    9616656-2020-01269
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 20, 2020
    Report Date
    February 4, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PN 32G 4MM 5B XTW EASYFLOW LA INSULIN WAS UNABLE TO BE DELIVERED. THIS OCCURRED WITH 12 NEEDLES OF LOT# 0091882 AND 10 WITH LOT# 9240206. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE PATIENT CONTACTED US TO REPORT A POSSIBLE QUALITY DEVIATION IN THE BD ULTRA FINE EASY FLOW 4MM NEEDLES. SHE MENTIONED THAT SHE HAS BEEN USING INSULIN FOR A SHORT TIME AND IN THE FIRST TWO ACQUIRED NEEDLE BOXES SHE NOTICED THAT SEVERAL NEEDLES CAME CLOGGED, WE QUESTIONED IF SHE PERFORMS THE FLOW TEST AND INFORMED THAT IN THE FIRST APPLICATION SHE DID NOT PERFORM IT, BUT AFTER THE SECOND APPLICATION SHE STARTED TO PERFORM THE TEST AND REALIZED THAT SOME NEEDLE WAS ALWAYS CLOGGED. TODAY ON NOVEMBER 20, WHEN SHE WENT TO DO THE INSULIN APPLICATION, SHE NOTICED THAT TWO NEEDLES WERE BLOCKED, ON THE THIRD ONE SHE WAS ABLE TO APPLY THE INSULIN.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9240206, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-08-28, MEDICAL DEVICE LOT #: 0091882, MEDICAL DEVICE EXPIRATION DATE: 2025-03-31, DEVICE MANUFACTURE DATE: 2020-03-31. INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD PN 32G 4MM 5B XTW EASYFLOW LA INSULIN WAS UNABLE TO BE DELIVERED. THIS OCCURRED WITH 12 NEEDLES OF LOT# 0091882 AND 10 WITH LOT# 9240206. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PATIENT CONTACTED US TO REPORT A POSSIBLE QUALITY DEVIATION IN THE BD ULTRA FINE EASY FLOW 4MM NEEDLES. SHE MENTIONED THAT SHE HAS BEEN USING INSULIN FOR A SHORT TIME AND IN THE FIRST TWO ACQUIRED NEEDLE BOXES SHE NOTICED THAT SEVERAL NEEDLES CAME CLOGGED, WE QUESTIONED IF SHE PERFORMS THE FLOW TEST AND INFORMED THAT IN THE FIRST APPLICATION SHE DID NOT PERFORM IT, BUT AFTER THE SECOND APPLICATION SHE STARTED TO PERFORM THE TEST AND REALIZED THAT SOME NEEDLE WAS ALWAYS CLOGGED. TODAY ON (B)(6), WHEN SHE WENT TO DO THE INSULIN APPLICATION, SHE NOTICED THAT TWO NEEDLES WERE BLOCKED, ON THE THIRD ONE SHE WAS ABLE TO APPLY THE INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494041 BD PN 32G 4MM 5B XTW EASYFLOW LA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR