BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G 4MM 5B XTW EASYFLOW LA

    MDR report key: 11032405 · Received December 17, 2020

    Report

    Report Number
    9616656-2020-01263
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 19, 2020
    Report Date
    January 8, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) SEALED 4MM, 32G PEN NEEDLE FROM LOT # 9240206. CUSTOMER STATES THAT THE TIP NEEDLE WITH ORANGE COLOR.. THE RETURNED PEN NEEDLE WAS EXAMINED AND NO FOREIGN MATTER WAS OBSERVED ON THE SAMPLE. 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 NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PN 32G 4MM 5B XTW EASYFLOW LA HAD A LOCKING PROBLEM AND WAS UNABLE TO DELIVER INSULIN. THERE WAS ALSO AN OCCURRENCE OF FOREIGN MATTER ON THE TIP OF THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER INFORMS: I BOUGHT 5 NEW PENS AND WENT TO APPLY THE INSULIN USING THE LOT MENTIONED IN MY PROTOCOL YESTERDAY. I HAD THE LOCKING PROBLEM AGAIN, AS DESCRIBED EARLIER. THEREFORE, I WILL BUY A NEW 4MM BD BOX TO SEE IF THE LOCKING PROBLEM WILL OCCUR AGAIN. I ASK YOU TO REGISTER THAT THE 1ST PEN IN THE FIRST APPLICATION WILL BE UNUSABLE IF THEY DO NOT TELL ME HOW TO REMEDY THIS REPEATED OCCURRENCE. INFO ADD: IN CONTACT WITH THE CUSTOMER BY PHONE, HE INFORMS THAT THE INSULIN HAS NOT COME OUT AND NOTICES THE TIP NEEDLE WITH ORANGE COLOR. WITH THE NEW NEEDLE PACK HE DID NOT IDENTIFY THE REPORTED DEVIATION.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PN 32G 4MM 5B XTW EASYFLOW LA HAD A LOCKING PROBLEM AND WAS UNABLE TO DELIVER INSULIN. THERE WAS ALSO AN OCCURRENCE OF FOREIGN MATTER ON THE TIP OF THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER INFORMS: I BOUGHT 5 NEW PENS AND WENT TO APPLY THE INSULIN USING THE LOT MENTIONED IN MY PROTOCOL YESTERDAY. I HAD THE LOCKING PROBLEM AGAIN, AS DESCRIBED EARLIER. THEREFORE, I WILL BUY A NEW 4MM BD BOX TO SEE IF THE LOCKING PROBLEM WILL OCCUR AGAIN. I ASK YOU TO REGISTER THAT THE 1ST PEN IN THE FIRST APPLICATION WILL BE UNUSABLE IF THEY DO NOT TELL ME HOW TO REMEDY THIS REPEATED OCCURRENCE. INFO ADD: IN CONTACT WITH THE CUSTOMER BY PHONE, HE INFORMS THAT THE INSULIN HAS NOT COME OUT AND NOTICES THE TIP NEEDLE WITH ORANGE COLOR. WITH THE NEW NEEDLE PACK HE DID NOT IDENTIFY THE REPORTED DEVIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490304 PN 32G 4MM 5B XTW EASYFLOW LA PEN NEEDLE FMI BECTON DICKINSON AND CO. 9240206

    Patients

    Seq Age Sex Outcome Treatment
    1