BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLE MINI

    MDR report key: 9887050 · Received March 26, 2020

    Report

    Report Number
    9616656-2020-00266
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    March 17, 2020
    Report Date
    March 19, 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
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR OPEN/PACKAGE SEAL TEAR DROP LABEL ON LOT # 9022898. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE PACKAGE WAS COMPROMISED AND STERILITY AFFECTED WITH A BD ULTRA-FINE¿ PEN NEEDLE MINI. THIS OCCURRED ON 2 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: IN THE NEEDLE BOX THERE WERE TWO NEEDLES WITHOUT THE SAFETY SEAL ON THE TOP, SHE SAYS THAT SHE CUT THEM WITH THE NEEDLE CUTTER AND DISCARDED THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350478 BD ULTRA-FINE¿ PEN NEEDLE MINI HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9022898

    Patients

    Seq Age Sex Outcome Treatment
    1 Other