BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD CORNWALL¿ DISPOSABLE SYRINGE FILLING SYSTEM WITH TUBING SET

    MDR report key: 7311612 · Received March 2, 2018

    Report

    Report Number
    9610847-2018-00035
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 8, 2018
    Report Date
    May 9, 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

    ADDITIONAL INFORMATION: ONE UNIT WAS RETURNED FOR EVALUATION IN CONNECTION TO THREE SEPARATE COMPLAINTS. THIS COMPLAINT IS LINKED TO 244212 AND 260570. THE ACTUAL LOT NUMBER FOR THIS COMPLAINT IS UNKNOWN. THE SAMPLE RETURNED HAS LOT INFORMATION USED FOR OUR INVESTIGATION. 1 SAMPLE WAS SENT/RECEIVED OF SYRINGE CORNWALL 10ML CATALOG 305224 WITH LOT NUMBER 7093584. MEDICAL DEVICE LOT NUMBER: 7093584, MEDICAL DEVICE EXPIRATION DATE: 04/30/2022 AND MEDICAL DEVICE MANUFACTURE DATE: 04/27/2017. INVESTIGATION RESULTS: OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS FOR ANY DAMAGE THAT COULD HAVE CAUSED THE REPORTED DEFECT AND NO ISSUES WERE FOUND. LEAK TESTING WAS THEN PERFORMED AND LEAKAGE WAS OBSERVED AT THE SPIKE VENT UNION. THIS ISSUE IS SUPPLIER RELATED AND OCCURRED DUE TO AN OUT OF SPECIFICATION COMPONENT. ACTION WILL BE TAKEN BY THE SUPPLIER TO ADDRESS OCCURRENCES OF THIS NATURE. DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS ASSOCIATED WITH THE LOT NUMBERS REPORTED REVEALED THAT NO DISCREPANCIES FOR LEAK OR ANY OTHER ISSUE WERE REPORTED. ADDITIONALLY, ALL PERSONNEL INVOLVED IN THE MANUFACTURING PROCESS WERE SKILLED AND TRAINED. PER INVESTIGATION ON PIR 244212 THE SAME INVESTIGATION CAN BE ASSIGNED AS BELOW: AFTER REVIEW THE SAMPLES RECEIVED AND ACCORDING TO CUSTOMER COMPLAINT ¿THE SYRINGES ARE LEAKING AT THE SPIKE.¿ 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 IT 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 NOT CONSIDERED AS A MANUFACTURING DEFECT DUE THAT WE DO NOT ASSEMBLE THE SPIKE AND THE VENT. THIS IS CONSIDERED AS A SUPPLIER ISSUE, A NOTIFICATION AND/OR ALERT WILL BE SENT TO THE SUPPLIER TO FOLLOW UP WITH THEM ON THIS ISSUE. 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 SEVERAL TECHNICIANS EXPERIENCED LEAKING WHILE USING 10 ML BD CORNWALL¿ DISPOSABLE SYRINGE FILLING SYSTEM WITH TUBING SETS. LEAKAGE WAS REPORTED WITHIN MINUTES FROM SPIKING THE BAG. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154940 10 ML BD CORNWALL¿ DISPOSABLE SYRINGE FILLING SYSTEM WITH TUBING SET LIQUID MEDICATION DISPENSER KYX BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other