BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 27GA X 103MM WHITACRE BULK

    MDR report key: 11845989 · Received May 18, 2021

    Report

    Report Number
    2618282-2021-00028
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 19, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BD CARIBE LTD.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2021-05-19. H6: INVESTIGATION SUMMARY: BASED ON THE SAMPLE PROVIDED TO BD FOR EVALUATION, THE REPORTED CONDITION WAS VERIFIED. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND NO DISCREPANCY OR NON-CONFORMANCE WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 27GA X 103MM WHITACRE BULK WAS DAMAGED. THIS OCCURRED ON 100 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 400444; BATCH NO.: 0041998. IT WAS REPORTED THAT MATERIAL IS DAMAGED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 27GA X 103MM WHITACRE BULK WAS DAMAGED. THIS OCCURRED ON 100 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 400444 BATCH. NO.: 0041998. IT WAS REPORTED THAT MATERIAL IS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742657 NEEDLE 27GA X 103MM WHITACRE BULK NEEDLE FMI BD CARIBE LTD. 0041998

    Patients

    Seq Age Sex Outcome Treatment
    1