BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CORNWALL¿ DISPOSABLE SYRINGE FILLING SYSTEM WITH TUBING SET

    MDR report key: 7434840 · Received April 16, 2018

    Report

    Report Number
    9610847-2018-00084
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    March 22, 2018
    Report Date
    May 15, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    KYX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FOR THE DATE RECEIVED BY MANUFACTURER. THIS FIELD HAS BEEN UPDATED TO REFLECT THE CORRECTED DATE OF 03/22/2018.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE SAMPLES WERE VISUALLY INSPECTED FOR ANY DAMAGE THAT THEY COULD HAVE AND NO ISSUES WERE FOUND, THEN THE SAMPLES WERE TESTED FOR LEAK, THE SPIKE WAS INSERTED INTO A SALINE WATER BOTTLE TO VERIFY IF THERE WAS A LEAKAGE INTO THE SPIKE, AFTER SEVERAL MINUTES IT WAS NOTICED THAT A WATER DROP WAS PRESENT IN THE SPIKE, THE LEAK IS IN THE SECTION OF THE SPIKE VENT UNION. THE DEFECT STATED BY THE CUSTOMER IS CONFIRMED. THIS IS A SUBASSEMBLY THAT IT IS RECEIVED FROM AN EXTERNAL SUPPLIER AND IT IS ASSEMBLED WITH THE SYRINGE SUB ASSEMBLY. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7093584. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. SAMPLE WAS RECEIVED FROM CUSTOMER COMPLAINT, WE COULD CONFIRM THE ISSUE STATED BY THE CUSTOMER AS A COMPONENT/SUPPLIER ISSUE.

    Additional Manufacturer Narrative · 1

    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 THE 10 ML BD CORNWALL¿ DISPOSABLE SYRINGE FILLING SYSTEM WITH TUBING SET WAS FOUND LEAKING AT THE VENT PORT DURING USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277963 BD CORNWALL¿ DISPOSABLE SYRINGE FILLING SYSTEM WITH TUBING SET LIQUID MEDICATION DISPENSER KYX BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7093584

    Patients

    Seq Age Sex Outcome Treatment
    1 Other