BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERLIFINE® MICRO PEN NEEDLES 31G X 8MM WITH PENTAPOINT¿ TECHNOLOGY

    MDR report key: 13537291 · Received February 15, 2022

    Report

    Report Number
    9616656-2022-00176
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    January 26, 2022
    Report Date
    March 11, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ZIP CODE : (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ZIP CODE : (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-02-21. H6: INVESTIGATION SUMMARY SIXTY FIVE SEALED AND SIX OPEN 31G X 8MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 0140224, CAT. NO. 320694. A CLOG TEST AND A FUNCTIONALITY TEST AS PER Q-SOP-183-DL WAS CARRIED OUT ON THE SIX OPEN SAMPLES ALONG WITH TWENTY FOUR SEALED 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE CARRIED OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BERLIFINE® MICRO PEN NEEDLES 31G X 8MM WITH PENTAPOINT¿ TECHNOLOGY WERE UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : ONE PHARMACY COMPLAINED THAT THE CANNULAS WERE NOT WORKING PROPERLY AS TOO LITTLE INSULIN CAME OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BERLIFINE® MICRO PEN NEEDLES 31G X 8MM WITH PENTAPOINT¿ TECHNOLOGY WERE UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : ONE PHARMACY COMPLAINED THAT THE CANNULAS WERE NOT WORKING PROPERLY AS TOO LITTLE INSULIN CAME OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BERLIFINE® MICRO PEN NEEDLES 31G X 8MM WITH PENTAPOINT¿ TECHNOLOGY WERE UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : ONE PHARMACY COMPLAINED THAT THE CANNULAS WERE NOT WORKING PROPERLY AS TOO LITTLE INSULIN CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734920 BERLIFINE® MICRO PEN NEEDLES 31G X 8MM WITH PENTAPOINT¿ TECHNOLOGY HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0140224

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown