BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE

    MDR report key: 8895799 · Received August 14, 2019

    Report

    Report Number
    3003152976-2019-00543
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    July 22, 2019
    Report Date
    September 11, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A TOTAL OF SIX SAMPLES WERE RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR MOLDING DEFECT WAS IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED MALFUNCTION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE LOTS 1807207, 1807267, 1901217, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS RELATED TO THIS ISSUE. TIP AND THREAD VERIFICATION TESTS ALONG WITH LEAKAGE TESTING IS PERFORMED DURING MANUFACTURING ACCORDING TO PROCEDURE. SAMPLES WERE INSPECTED AND FOUND TO BE WITHIN SPECIFICATION, SYRINGES WERE SUCCESSFULLY CONNECTED TO A 18GA X 1IN NEEDLE WITHOUT ISSUE AND NO LEAKAGES WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE WORKER BEGAN FILLING A SYRINGE AND DURING THE FILLING THE SYRINGE PLUNGER WAS RELEASED AND THE FILLING FLUID WAS SPILLED. THE WORKERS REPORTED THE INCIDENT AND THEN ENTERED TO EXAMINE THE PHENOMENON. WE FOUND THAT WHEN INSERTING THE NEEDLE IN SOME OF THE SYRINGES THERE IS RESISTANCE AND AS A RESULT OF THE FILLING THE AIR HAS NO WAY OUT AND THE TEST IS RELEASED."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1807207. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. DEVICE MANUFACTURE DATE: 2018-07-09. MEDICAL DEVICE LOT #: 1810267. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-10-25. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE WORKER BEGAN FILLING A SYRINGE AND DURING THE FILLING THE SYRINGE PLUNGER WAS RELEASED AND THE FILLING FLUID WAS SPILLED. THE WORKERS REPORTED THE INCIDENT AND THEN ENTERED TO EXAMINE THE PHENOMENON. WE FOUND THAT WHEN INSERTING THE NEEDLE IN SOME OF THE SYRINGES THERE IS RESISTANCE AND AS A RESULT OF THE FILLING THE AIR HAS NO WAY OUT AND THE TEST IS RELEASED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685425 BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other