BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 18694699 · Received February 13, 2024

    Report

    Report Number
    1911916-2024-00087
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    December 20, 2023
    Report Date
    March 18, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), FOLLOW UP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBER 3202526. 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, 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.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED MATERIAL#: 309653, LOT#: 3202526. IT WAS REPORTED BY THE CUSTOMER THAT THE WHITE FOREIGN PARTICLE IN OUR FINAL T-CELL PRODUCT. TO WHOM IT MAY CONCERN WE ARE INVESTIGATING TO DETERMINE THE SOURCE OF A WHITE FOREIGN PARTICLE IN OUR FINAL T-CELL PRODUCT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE ARE INVESTIGATING TO DETERMINE THE SOURCE OF A WHITE FOREIGN PARTICLE IN OUR FINAL T-CELL PRODUCT. TO WHOM IT MAY CONCERN WE ARE INVESTIGATING TO DETERMINE THE SOURCE OF A WHITE FOREIGN PARTICLE IN OUR FINAL T-CELL PRODUCT. FOLLOW UP: 1. PLEASE PROVIDE DATE OF EVENT. 12/20/23. 2. 2.IS THERE SAMPLE AVAILABLE? I DO HAVE A FEW UNITS OF THE LOT IN QUESTION AVAILABLE.

    Description of Event or Problem · 0

    MATERIAL#: 309653, LOT#: 3202526. IT WAS REPORTED BY THE CUSTOMER THAT THE WHITE FOREIGN PARTICLE IN OUR FINAL T-CELL PRODUCT. TO WHOM IT MAY CONCERN WE ARE INVESTIGATING TO DETERMINE THE SOURCE OF A WHITE FOREIGN PARTICLE IN OUR FINAL T-CELL PRODUCT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE ARE INVESTIGATING TO DETERMINE THE SOURCE OF A WHITE FOREIGN PARTICLE IN OUR FINAL T-CELL PRODUCT. TO WHOM IT MAY CONCERN WE ARE INVESTIGATING TO DETERMINE THE SOURCE OF A WHITE FOREIGN PARTICLE IN OUR FINAL T-CELL PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137008 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 3202526 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown