BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25GA 1IN

    MDR report key: 12616549 · Received October 12, 2021

    Report

    Report Number
    3002682307-2021-00545
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 14, 2021
    Report Date
    November 16, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    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: D.4. MEDICAL DEVICE LOT #: 200524. D.4. MEDICAL DEVICE EXPIRATION DATE: 1/31/2025. H.4. DEVICE MANUFACTURE DATE: 2/4/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 200524. 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, THREE UNPACKAGED NEEDLE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH MICROSCOPIC EXAMINATION, NO FOREIGN MATTER OR DISCOLORATION COULD BE OBSERVED. A COTTON SWAB TEST WAS THEN PERFORMED ON THE RETURNED NEEDLES BY RUNNING A COTTON STICK ALONG THE CANNULA SURFACES. THIS IS AN OBJECTIVE TEST TO OBTAIN A COMPARISON BETWEEN THE RETURNED SAMPLES AND OTHER ¿REGULAR PRODUCT.¿ THE COTTON SWAB TEST RESULTS SHOWED A LACK OF RESIDUE ON THE RETURNED NEEDLES; LESS THAN OTHER REGULAR PRODUCT TESTED AND COMPETITOR PRODUCT TESTED. BASED ON THE INVESTIGATION RESULTS, THE REPORTED DEFECT COULD NOT BE CONFIRMED AND THEREFORE, A CAUSE RELATED TO THE MANUFACTURING COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 25GA 1IN HAD DISCOLORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM SENDING YOU THE MICROLANCE 3 CANNULAS THAT OUR CUSTOMER REPORTED AS DEFECTIVE DUE TO QUALITY ISSUES (COLORATION OF THE METAL). PLEASE ISSUE A CREDIT NOTE FOR THE COST OF SENDING THEM TO YOU AS WELL AS FOR THE VALUE OF THE GOODS. WE DO NOT WANT TO RECEIVE SUBSTITUTION PRODUCTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 200524. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 25GA 1IN HAD DISCOLORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM SENDING YOU THE MICROLANCE 3 CANNULAS THAT OUR CUSTOMER REPORTED AS DEFECTIVE DUE TO QUALITY ISSUES (COLORATION OF THE METAL). PLEASE ISSUE A CREDIT NOTE FOR THE COST OF SENDING THEM TO YOU AS WELL AS FOR THE VALUE OF THE GOODS. WE DO NOT WANT TO RECEIVE SUBSTITUTION PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511370 NEEDLE 25GA 1IN NEEDLE FMI BECTON DICKINSON, S.A. 200524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown