BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 20096830 · Received August 29, 2024

    Report

    Report Number
    1911916-2024-00634
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    July 28, 2024
    Report Date
    September 3, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 302830 AND LOT NUMBER 4122296. 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

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

    Description of Event or Problem · 0

    MATERIAL#: 382830; BATCH NUMBER#: 4122296. IT WAS REPORTED BY CUSTOMER THAT PHARMACY TECHNICIAN REMOVED A 20 ML BD SYRINGE, DURING REVIEW OF ITEM, IT WAS NOTED THAT THE VOLUME GRADIENTS WERE NOT CALIBRATED CORRECTLY WITH THE LINES STARTING TOO FAR DOWN THE SYRINGE, RESULTING IN 7 ML OF FLUID IN THE SYRINGE WHEN IT WAS DRAWN BACK TO THE 5 ML LINE. SYRINGE WAS REMOVED FROM THE AREA AND REMAINING SUPPLY WAS REVIEWED TO ENSURE ACCURACY. RCC RECEIVED A COMPLAINT VIA EMAIL. PHARMACY TECHNICIAN REMOVED A 20 ML BD SYRINGE, DURING REVIEW OF ITEM, IT WAS NOTED THAT THE VOLUME GRADIENTS WERE NOT CALIBRATED CORRECTLY WITH THE LINES STARTING TOO FAR DOWN THE SYRINGE, RESULTING IN 7 ML OF FLUID IN THE SYRINGE WHEN IT WAS DRAWN BACK TO THE 5 ML LINE. SYRINGE WAS REMOVED FROM THE AREA AND REMAINING SUPPLY WAS REVIEWED TO ENSURE ACCURACY. LOT - 4122296.

    Description of Event or Problem · 0

    MATERIAL#: 382830 . BATCH NUMBER#: 4122296. IT WAS REPORTED BY CUSTOMER THAT PHARMACY TECHNICIAN REMOVED A 20 ML BD SYRINGE, DURING REVIEW OF ITEM, IT WAS NOTED THAT THE VOLUME GRADIENTS WERE NOT CALIBRATED CORRECTLY WITH THE LINES STARTING TOO FAR DOWN THE SYRINGE, RESULTING IN 7 ML OF FLUID IN THE SYRINGE WHEN IT WAS DRAWN BACK TO THE 5 ML LINE. SYRINGE WAS REMOVED FROM THE AREA AND REMAINING SUPPLY WAS REVIEWED TO ENSURE ACCURACY. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED PHARMACY TECHNICIAN REMOVED A 20 ML BD SYRINGE, DURING REVIEW OF ITEM, IT WAS NOTED THAT THE VOLUME GRADIENTS WERE NOT CALIBRATED CORRECTLY WITH THE LINES STARTING TOO FAR DOWN THE SYRINGE, RESULTING IN 7 ML OF FLUID IN THE SYRINGE WHEN IT WAS DRAWN BACK TO THE 5 ML LINE. SYRINGE WAS REMOVED FROM THE AREA AND REMAINING SUPPLY WAS REVIEWED TO ENSURE ACCURACY. LOT - 4122296.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095665 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON 4122296 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown