BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G 4MM 5B XTW EASYFLOW LA

    MDR report key: 10864410 · Received November 18, 2020

    Report

    Report Number
    9616656-2020-01163
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 26, 2020
    Report Date
    March 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

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. 1 PHOTO OF A KWIKPEN PEN INJECTOR (NON-BD PRODUCT) WAS PROVIDED. THE CUSTOMER REPORTED RESISTANCE TO FIT THE PEN, AND AFTER APPLICATION WHEN REMOVING THE NEEDLE FROM THE PEN TO DISCARD IT DID NOT COME OUT, SO HE USED A CLOTH TO PULL AND ONLY THE TRANSPARENT BASE CAME OUT AND THE NEEDLE STAYED INSIDE THE PEN. THE PHOTO WAS REVIEWED AND NO DEFECTS ON A BD PRODUCT WERE OBSERVED, THEREFORE, THE ALLEGED ISSUE COULD NOT BE DETERMINED FROM THE PHOTO PROVIDED ALONE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PN 32G 4MM 5B XTW EASYFLOW LA WAS DIFFICULT TO REMOVE FROM THE PEN, AND GOT STUCK AND BROKE OFF INSIDE IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "THE PATIENT CONTACTED US TO REPORT A POSSIBLE QUALITY DEVIATION IN THE BD ULTRA-FINE EASY FLOW 4MM NEEDLES (LOT 9240206 FAB 09/2019 EXPIR 08/2024). HE REPORTED THAT HE HAS USED THE NEEDLES FOR INSULIN APPLICATION FOR MORE THAN 10 YEARS AND THAT IN THE LAST BATCH ACQUIRED A NEEDLE WAS APPARENTLY NORMAL, HE EVEN APPLIED INSULIN, BUT MENTIONED THAT HE HAD A LITTLE DIFFICULTY: A RESISTANCE TO FIT THE PEN , AFTER APPLICATION WHEN REMOVING THE NEEDLE FROM THE PEN TO DISCARD IT DID NOT COME OUT, SO HE USED A CLOTH TO PULL AND ONLY THE TRANSPARENT BASE CAME OUT AND THE NEEDLE STAYED INSIDE THE PEN. HOWEVER, WE QUESTIONED WHETHER THE NEEDLE GOT STUCK INSIDE THE PEN, THE CUSTOMER SAID YES. THEN HE GOT IN TOUCH WITH THE PEN MANUFACTURER WHO ASKED TO CONTACT US. IN THE MEANTIME HE MANAGED TO REMOVE THE TIP OF THE NEEDLE FROM INSIDE THE PEN, EVEN SO THE PEN IS CLOGGED AND HE IS NO LONGER ABLE TO USE IT."

    Additional Manufacturer Narrative · 1

    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 THE PN 32G 4MM 5B XTW EASYFLOW LA WAS DIFFICULT TO REMOVE FROM THE PEN, AND GOT STUCK AND BROKE OFF INSIDE IT. 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 (LOT 9240206 FAB 09/2019 EXPIR 08/2024). HE REPORTED THAT HE HAS USED THE NEEDLES FOR INSULIN APPLICATION FOR MORE THAN 10 YEARS AND THAT IN THE LAST BATCH ACQUIRED A NEEDLE WAS APPARENTLY NORMAL, HE EVEN APPLIED INSULIN, BUT MENTIONED THAT HE HAD A LITTLE DIFFICULTY: A RESISTANCE TO FIT THE PEN , AFTER APPLICATION WHEN REMOVING THE NEEDLE FROM THE PEN TO DISCARD IT DID NOT COME OUT, SO HE USED A CLOTH TO PULL AND ONLY THE TRANSPARENT BASE CAME OUT AND THE NEEDLE STAYED INSIDE THE PEN. HOWEVER, WE QUESTIONED WHETHER THE NEEDLE GOT STUCK INSIDE THE PEN, THE CUSTOMER SAID YES. THEN HE GOT IN TOUCH WITH THE PEN MANUFACTURER WHO ASKED TO CONTACT US. IN THE MEANTIME HE MANAGED TO REMOVE THE TIP OF THE NEEDLE FROM INSIDE THE PEN, EVEN SO THE PEN IS CLOGGED AND HE IS NO LONGER ABLE TO USE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330468 PN 32G 4MM 5B XTW EASYFLOW LA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9240206

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR