BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PRO PEN NEEDLE

    MDR report key: 13427821 · Received February 2, 2022

    Report

    Report Number
    9616656-2022-00081
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 18, 2022
    Report Date
    February 24, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: INVESTIGATION SUMMARY: THREE OPEN 32G X 4MM PEN NEEDLE SAMPLES AND ONE PHOTO WERE RETURNED FROM LOT. NO. 1082141, CAT. NO. 320561. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTO AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON TWO SAMPLES AND NO ISSUES WERE OBSERVED WITH THE REMAINING SAMPLE. 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. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PRO PEN NEEDLE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "CUSTOMER CLAIMS THAT THE NEEDLES ARE DAMAGED OFTEN."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ PRO PEN NEEDLE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "CUSTOMER CLAIMS THAT THE NEEDLES ARE DAMAGED OFTEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85074 BD ULTRA-FINE¿ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1082141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown