BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 8769700 · Received July 8, 2019

    Report

    Report Number
    1911916-2019-00671
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 18, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: ONE (1) SAMPLE WAS RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. THE SAMPLE WAS RETURNED WITH AN OPENED BLISTER PACK. THE SAMPLE WAS ANALYZED BY DRAWING 60ML OF A WATER/DYE SOLUTION INTO THE SYRINGE. NO LEAKAGE WAS OBSERVED. THE TIP OF THE SYRINGE WAS THEN BLOCKED AND THE PLUNGER WAS ATTEMPTED TO BE DEPRESSED. NO LEAKAGE WAS OBSERVED DURING THIS TEST. WHILE FAILURE MODE COULD NOT BE REPLICATED, LEAKAGE CAN BE CAUSED BY THE INTERACTION BETWEEN THE BARREL INSIDE DIAMETER, THE STOPPER OUTSIDE DIAMETER, AND PLUNGER ROD BAYONET OUTSIDE DIAMETER AND FORCES APPLIED DURING USE. THE SYRINGE IS MORE LIKELY TO LEAK WHEN FORCES ARE APPLIED TO THE PLUNGER ROD WHEN FULLY EXTENDED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAKAGE PAST STOPPER FOR LOT #8220751 ITEM #309653. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. ROOT CAUSE DESCRIPTION: WHILE FAILURE MODE COULD NOT BE REPLICATED, LEAKAGE CAN BE CAUSED BY THE INTERACTION BETWEEN THE BARREL INSIDE DIAMETER, THE STOPPER OUTSIDE DIAMETER, AND PLUNGER ROD BAYONET OUTSIDE DIAMETER AND FORCES APPLIED DURING USE. THE SYRINGE IS MORE LIKELY TO LEAK WHEN FORCES ARE APPLIED TO THE PLUNGER ROD WHEN FULLY EXTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A BD 60ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LEAKAGE THRU THE STOPPER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560192 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON AND COMPANY 8220751 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other