BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18097868 · Received November 8, 2023

    Report

    Report Number
    1213809-2023-01237
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 16, 2023
    Report Date
    January 10, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385108 AND LOT NUMBER 309703. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, THE PHOTO PROVIDED IS NOT APPLICABLE TO THE COMPLAINT OF A 5ML PRODUCT CODE, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. OTHER LOT NUMBER INCLUDES 3150597. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. OTHER DEVICE MANUFACTURE DATE IS 06/16/2023.

    Description of Event or Problem · 0

    MATERIAL#: 309703 BATCH#: 3118878, 3150597, 3096912. IT WAS REPORTED BY CUSTOMER THAT CUSTOMER REPORTED HAVING ISSUES WITH THE LABELS PEELING OFF THE 5 ML AND 10 ML SYRINGES. I HAVE ATTACHED A PHOTO OF A 10 ML SYRINGE WITH THE PEELING LABEL. I UNFORTUNATELY DO NOT HAVE ANY EXAMPLE OF THE 5 ML TO SHOW YOU. VERBATIM: HELLO, SORRY FOR THE DELAY, WE SEEMED TO HAVE MISSED YOUR PREVIOUS EMAIL. 1.SAMPLE STATUS? AVAILABLE/NOT AVAILABLE- NOT AVAILABLE. 2.PATIENT STATUS?- NOT APPLICABLE . 3.DATE OF EVENT?- ONGOING . 4. PLEASE PROVIDE BATCH NUMBER?- ALL. 5. PLEASE PROVIDE MATERIAL NUMBER?- 309702, 309703, 309605. IT WAS REPORTED BY CUSTOMER THAT CUSTOMER REPORTED HAVING ISSUES WITH THE LABELS PEELING OFF THE 5 ML AND 10 ML SYRINGES. I HAVE ATTACHED A PHOTO OF A 10 ML SYRINGE WITH THE PEELING LABEL. I UNFORTUNATELY DO NOT HAVE ANY EXAMPLE OF THE 5 ML TO SHOW YOU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE LABEL CONTENT WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE HAVING ISSUES WITH THE LABELS PEELING OFF THE 5 ML AND 10 ML SYRINGES." SORRY FOR THE DELAY, WE SEEMED TO HAVE MISSED YOUR PREVIOUS EMAIL. SAMPLE STATUS? AVAILABLE/NOT AVAILABLE- NOT AVAILABLE. PATIENT STATUS?- NOT APPLICABLE . DATE OF EVENT?- ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74416 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3118878 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown