BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25GA 1IN

    MDR report key: 12271643 · Received August 3, 2021

    Report

    Report Number
    3002682307-2021-00381
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 6, 2021
    Report Date
    October 26, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 2021-10-14. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 200503. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION. THROUGH EXAMINATION OF THE SAMPLES, NO SIGNS OF FOREIGN MATTER OR DEFECT CAN BE OBSERVED TO CONFIRM THE REPORTED ISSUE. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 25GA 1IN WAS DAMAGED AND HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER USES THIS PRODUCT FOR COVID VACCINATION. ACCORDING TO THE CUSTOMER'S REPORT, TINY SPOTS CAN BE SEEN ON THE NEEDLE (WHETHER THIS IS AN FM OR A SCRATCH IS UNKNOWN).

    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 25GA 1IN WAS DAMAGED AND HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER USES THIS PRODUCT FOR COVID VACCINATION. ACCORDING TO THE CUSTOMER'S REPORT, TINY SPOTS CAN BE SEEN ON THE NEEDLE (WHETHER THIS IS AN FM OR A SCRATCH IS UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163702 NEEDLE 25GA 1IN NEEDLE FMI BECTON DICKINSON, S.A. 200503

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown