BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE BOIN TUBE 10ML 21G 1-1/4IN

    MDR report key: 9156062 · Received October 4, 2019

    Report

    Report Number
    2243072-2019-02203
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 2, 2019
    Report Date
    October 10, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATIONS: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1903142. VISUAL INSPECTION OF THE COMPLAINT SAMPLE: FROM VISUAL INSPECTION, SBDM FOUND CRACK ON THE TIP OF THE COMPLAINT SAMPLE. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS HOUSE SAMPLES FROM LOTS 1902222, 1903142 & 1906112, NO ABNORMALITY OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 1903142, NO ABNORMALITY OBSERVED. ROOT CAUSE: FROM INVESTIGATION RESULT OF THE COMPLAINT SAMPLES, A CRACK ON THE TIP OF COMPLAINT SAMPLE WAS NOTICED. THE LIKELY CAUSE OF THE CRACK ON TIP MAY BE OCCURRED DURING SYRINGE ASSEMBLY PROCESS. THIS IS BECAUSE THE COMPLAINT SAMPLE WAS NOT SUPPLIED ON THE ASSEMBLY MACHINE PROPERLY THROUGH GUIDE IN THE ASSEMBLY MACHINE AND WHEN THE COMPLAINT SAMPLE FORCE TO BE BACK ON THE GUIDE PROPERLY THE TIP WAS DAMAGED. THIS TEMPORARY MALFUNCTION OF THE SYRINGE ASSEMBLY MACHINE CAUSED THE COMPLAINT CASE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE BOIN TUBE 10ML 21G 1-1/4IN TIP WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POOR SYRINGE TIP. THE NEEDLE CANNOT BE CONNECTED BECAUSE OF POOR SYRINGE TIPS.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 SYRINGE BOIN TUBE 10ML 21G 1-1/4IN TIP WAS DAMAGED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: POOR SYRINGE TIP. THE NEEDLE CANNOT BE CONNECTED BECAUSE OF POOR SYRINGE TIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953121 SYRINGE BOIN TUBE 10ML 21G 1-1/4IN SYRINGE FMF BECTON DICKINSON 1903142

    Patients

    Seq Age Sex Outcome Treatment
    1 Other