BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 19250213 · Received May 6, 2024

    Report

    Report Number
    1911916-2024-00329
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 30, 2024
    Report Date
    June 11, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    PR 10126409 FOLLOW UP. IT WAS REPORTED THE SYRINGES EXHIBIT FAINT GRADIENT LINES THAT APPEAR TO STEM FROM A PRINTING IRREGULARITY. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A SYRINGE WITH ACCEPTABLE IMPERFECTIONS OF THE SYRINGE BARREL SCALE PRINTING. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4080153. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED BUT IS CONSIDERED AN ACCEPTABLE IMPERFECTION.

    Description of Event or Problem · 0

    MATERIAL#: 309653 BATCH#: 4080153 IT WAS REPORTED BY THE CUSTOMER THAT THE OUR BATCH OF 50ML SYRINGES [LOT 4080153 / EXP 2029-03-31] EXHIBITS FAINT GRADIENT LINES THAT APPEAR TO STEM FROM A PRINTING IRREGULARITY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I TRUST THIS MESSAGE FINDS YOU WELL. I AM REACHING OUT ON BEHALF OF UCSF OWENS PHARMACY TO BRING TO YOUR ATTENTION AN ISSUE REGARDING ONE OF YOUR PRODUCTS. SPECIFICALLY, OUR BATCH OF 50ML SYRINGES [LOT 4080153 / EXP 2029-03-31] EXHIBITS FAINT GRADIENT LINES THAT APPEAR TO STEM FROM A PRINTING IRREGULARITY (PLEASE REFER TO THE ATTACHED IMAGE FOR CLARITY). ADDITIONAL INFORMATION: DATE OF EVENT - 4/30/2024 3. DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? - NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 309653, BATCH#: 4080153. IT WAS REPORTED BY THE CUSTOMER THAT THE OUR BATCH OF 50ML SYRINGES [LOT 4080153 / EXP 2029-03-31] EXHIBITS FAINT GRADIENT LINES THAT APPEAR TO STEM FROM A PRINTING IRREGULARITY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I TRUST THIS MESSAGE FINDS YOU WELL. I AM REACHING OUT ON BEHALF OF UCSF OWENS PHARMACY TO BRING TO YOUR ATTENTION AN ISSUE REGARDING ONE OF YOUR PRODUCTS. SPECIFICALLY, OUR BATCH OF 50ML SYRINGES [LOT 4080153 / EXP 2029-03-31] EXHIBITS FAINT GRADIENT LINES THAT APPEAR TO STEM FROM A PRINTING IRREGULARITY (PLEASE REFER TO THE ATTACHED IMAGE FOR CLARITY). COULD YOU PLEASE ADVISE ON THE APPROPRIATE STEPS TO ADDRESS THIS MATTER? YOUR GUIDANCE ON THE NEXT COURSE OF ACTION WOULD BE GREATLY APPRECIATED. BEST REGARDS, (B)(6). COMMENTS ON (B)(6) 2024. 1. PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? - (B)(6). 2. DATE OF EVENT - 4/30/2024. 3. DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? - NO. 4. NUMBER OF PRODUCT HAVING THIS ISSUE? - ABOUT 200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768011 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4080153 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown