BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 9983400 · Received April 21, 2020

    Report

    Report Number
    9616656-2020-00340
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    April 1, 2020
    Report Date
    April 22, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS AND ONE OPEN 31G X 5MM PEN NEEDLE SAMPLE WERE RETURNED FROM LOT. NO. 9141564, CAT. NO. 320129. VISUAL EXAMINATION WAS CARRIED OUT ON RETURNED PHOTOS AND A CLOG TEST WAS CARRIED OUT ON ONE THE OPEN SAMPLE 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. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLE OR PHOTOS THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRIMING MEDICATION DIDN'T FLOW WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: DRUG DIDN'T COME OUT DURING AIR PURGE.

    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 DURING PRIMING MEDICATION DIDN'T FLOW WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DRUG DIDN'T COME OUT DURING AIR PURGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443883 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9141564

    Patients

    Seq Age Sex Outcome Treatment
    1 Other