BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NDL 32G 4MM HP

    MDR report key: 9770662 · Received February 28, 2020

    Report

    Report Number
    9616656-2020-00169
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    February 5, 2020
    Report Date
    March 9, 2020
    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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY THIRTY FIVE SEALED AND INTACT 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 9141583, CAT. NO. 320561. A CLOG TEST WAS CARRIED OUT ON ALL THIRTY FIVE SAMPLES AS PER TP700483 AND NO ISSUES WERE OBSERVED. INVESTIGATION CONCLUSION A CLOG TEST WAS CARRIED OUT ON ALL THIRTY FIVE SAMPLES AS PER TP700483 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. ROOT CAUSE DESCRIPTION NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. RATIONALE BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSULIN LEAKS FROM SIDE OF PEN DURING USE WITH A BD PEN NDL 32G 4MM HP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: INSULIN LEAKS FROM THE SIDE OF THE PEN.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN LEAKS FROM SIDE OF PEN DURING USE WITH A BD PEN NDL 32G 4MM HP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: INSULIN LEAKS FROM THE SIDE OF THE PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235727 BD PEN NDL 32G 4MM HP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9141583

    Patients

    Seq Age Sex Outcome Treatment
    1 Other