BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32GA 4MM 14BAG 700CASE JP

    MDR report key: 8871994 · Received August 7, 2019

    Report

    Report Number
    9616656-2019-00719
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 23, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWENTY ONE SEALED AND THREE OPEN 32G X 4MM PEN NEEDLE SAMPLES AND FOUR PHOTOS WERE RETURNED FROM LOT. NO.8233897 CAT NO. 320136. CLOG TESTING AS PER TP700483 WAS CARRIED OUT ON TWENTY ONE SAMPLES AND NO ISSUES WERE OBSERVED. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES/PHOTOS THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NDL 32GA 4MM 14BAG 700CASE JP EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE PATIENT CONDUCTED AIR PURGE WITH 2 UNITS, DRUG DIDN'T COME OUT. HOWEVER DRUG CAME OUT WITH (B)(4) UNITS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, 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 THE PEN NDL 32GA 4MM 14BAG 700CASE JP EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE PATIENT CONDUCTED AIR PURGE WITH 2 UNITS, DRUG DIDN'T COME OUT. HOWEVER DRUG CAME OUT WITH 6 UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666541 PEN NDL 32GA 4MM 14BAG 700CASE JP PEN NEEDLE FMI BECTON DICKINSON AND CO. 8233897

    Patients

    Seq Age Sex Outcome Treatment
    1 Other