BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 21GA 1-1/2IN

    MDR report key: 11299612 · Received February 9, 2021

    Report

    Report Number
    3002682307-2021-00044
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 14, 2021
    Report Date
    February 19, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 180107 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. ALL PULL TESTS PERFORMED FOR THE LOT PRIOR TO RELEASE WERE FOUND TO BE WITHIN SPECIFICATION. THE TEST RESULTS SHOWED THAT A SIGNIFICANT FORCE WAS NECESSARY TO SEPARATE THE CANNULA FROM THE HUB COMPONENT AND NO ABNORMALITIES IN THE PRODUCT WAS FOUND DURING PRODUCTION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, THE PRODUCT WAS FOUND TO HAVE A BROKEN HUB COMPONENT. BASED ON THE REVIEW OF THE PRODUCTION HISTORY AND SPECIFICATION TESTING, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. NEEDLE PUNCTURES SHOULD BE MADE AT A 90º ANGLE TO PREVENT THE RISK OF DAMAGE TO THE NEEDLE. IT IS POSSIBLE THAT THIS INCIDENT WAS RELATED TO THE HANDLING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 21GA 1-1/2IN WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WOULD LIKE TO REPORT A QUALITY DEFECT IN A BD MICROLANCE 3 NEEDLE. DURING THE RECONSTITUTION OF A CHEMOTHERAPY VIAL, THE NEEDLE BROKE AT THE LUER PART WHEN INSERTING IT INTO THE LID OF THE VIAL AND COULD THEREFORE NOT BE USED. NO CONSEQUENCES FOR THE PATIENT. THE PERSONNEL WERE NOT EXPOSED TO ANY HAZARDOUS PRODUCT, NOR WAS THERE ANY CHANGE IN TREATMENT. THE PREPARER WHO RECONSTITUTED THE CHEMOTHERAPY VIAL HAD TO REMOVE THE BROKEN LUER PART OF THE SYRINGE TO INSERT ANOTHER NEEDLE AND RETRIEVE THE PRODUCT, WHICH REQUIRED ADDITIONAL HANDLING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 21GA 1-1/2IN WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WOULD LIKE TO REPORT A QUALITY DEFECT IN A BD MICROLANCE 3 NEEDLE. DURING THE RECONSTITUTION OF A CHEMOTHERAPY VIAL, THE NEEDLE BROKE AT THE LUER PART WHEN INSERTING IT INTO THE LID OF THE VIAL AND COULD THEREFORE NOT BE USED. NO CONSEQUENCES FOR THE PATIENT. THE PERSONNEL WERE NOT EXPOSED TO ANY HAZARDOUS PRODUCT, NOR WAS THERE ANY CHANGE IN TREATMENT. THE PREPARER WHO RECONSTITUTED THE CHEMOTHERAPY VIAL HAD TO REMOVE THE BROKEN LUER PART OF THE SYRINGE TO INSERT ANOTHER NEEDLE AND RETRIEVE THE PRODUCT, WHICH REQUIRED ADDITIONAL HANDLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198964 NEEDLE 21GA 1-1/2IN NEEDLE FMI BECTON DICKINSON, S.A. 180107

    Patients

    Seq Age Sex Outcome Treatment
    1