BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CORNWALL¿ DISPOSABLE SYRINGE FILLING SYSTEM W/TUBING SET

    MDR report key: 7411010 · Received April 10, 2018

    Report

    Report Number
    9610847-2018-00082
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 21, 2018
    Report Date
    May 10, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR STATED AN INCORRECT "DATE RECEIVED BY MANUFACTURER". THE CORRECT DATE IS 03/21/2018.

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253981 BD CORNWALL¿ DISPOSABLE SYRINGE FILLING SYSTEM W/TUBING SET SYRINGE KYX BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7093584

    Patients

    Seq Age Sex Outcome Treatment
    1 Other