BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML REG PR SALINE 10ML FILL

    MDR report key: 21784795 · Received April 7, 2025

    Report

    Report Number
    1911916-2025-00266
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 10, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 (B)(4) FOLLOW UP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306546 AND LOT NUMBER 4211845. 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.

    Description of Event or Problem · 0

    MATERIAL: 306546, BATCH#: 4211845. IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE FINDING "CLOUDY" FLUSHES. VERBATIM: I HAVE A REPORT FROM OUR ED THAT THEY ARE FINDING "CLOUDY" FLUSHES. NOT SURE IF THAT'S TO BE EXPECTED OR NOT BUT WE WANT TO BE SAFE. I SIFTED THROUGH THE BAG THEY GAVE ME AND THESE ARE THE LOT #S I FOUND: 4241906, 4211845. ADDITIONAL INFORMATION: VERIFY WHAT PART OF THE PRODUCT IS CLOUDY? THE SYRINGES OR THE SOLUTION INSIDE ? IT APPEARS TO BE THE SOLUTION ITSELF THAT IS CLOUDY. WAS THERE ANY HARM TO THE PATIENT/CAREGIVER? (DETAIL) THERE HAVE BEEN NO REPORTED ADVERSE EVENTS IN RELATION TO THE FLUSHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613447 SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH FOZ BECTON DICKINSON 4211845

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown