BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CORNWALL¿ DISPOSABLE SYRINGE FILLING SYSTEM WITH TUBING SET

    MDR report key: 7859925 · Received September 10, 2018

    Report

    Report Number
    9610847-2018-00296
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Date of Event
    August 21, 2018
    Report Date
    November 2, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR FOR LOT NUMBER: 7093584 WAS REVIEWED AND NO QNS OR OTHER EVENTS WERE RELATED TO THE COMPLAINT STATED BY THE CUSTOMER. MATERIAL 305224 WITH LOT NUMBER: 7093584 WAS MANUFACTURED ON APRIL 11, 2017. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED. DURING MANUFACTURING OF THIS LOT NUMBER SEVERAL INSPECTION WERE PERFORMED TO THE MATERIAL AND NO SIMILAR ISSUES TO THE ONE STATED BY THE CUSTOMER WERE FOUND. THESE INSPECTIONS WERE PERFORMED BY THE QA TECH AND PRODUCTION PERSONNEL, DURING THE INSPECTIONS NO ISSUES WERE FOUND. ALL RELEVANT INFORMATION DURING THE DHR REVIEW SHOWN THAT MEET ALL ESTABLISHED MANUFACTURING CRITERIA. THE SAMPLES RECEIVED 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 IT IS CONFIRMED .THIS IS A SUBASSEMBLY THAT IT IS RECEIVED FROM AN EXTERNAL SUPPLIER AND IT IS ASSEMBLED WITH THE SYRINGE SUB ASSEMBLY. THIS IS CONSIDERED AS A SUPPLIER ISSUE. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEWING OF PFMEA¿S RM6449; 5225 WAS DONE. THERE ARE PROPER CONTROLS IN PLACE TO DETECT PRODUCT MALFUNCTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 10 ML BD CORNWALL¿ DISPOSABLE SYRINGE FILLING SYSTEM WITH TUBING SET, IS LEAKING AT THE CONNECTOR BETWEEN SPIKE ADAPTOR AND HOUSING. DURING USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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, IS LEAKING AT THE CONNECTOR BETWEEN SPIKE ADAPTOR AND HOUSING. DURING USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703657 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