BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CORNWALL¿ DISPOSABLE SYRINGE FILLING SYSTEM WITH TUBING SET

    MDR report key: 7320309 · Received March 7, 2018

    Report

    Report Number
    9610847-2018-00054
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 27, 2018
    Report Date
    March 21, 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

    INVESTIGATION SUMMARY: NO SAMPLES WERE SENT/RECEIVED OF SYRINGE CORNWALL 10ML CATALOG 305224 WITH LOT NUMBER 7093584 FOR THIS PIR. ACCORDING TO ISSUE STATED BY CUSTOMER ¿THERE IS LEAKAGE FROM THE SYRINGE.¿ PER INVESTIGATION ON PIR (B)(4) 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. SAMPLES WAS RECEIVED FROM CUSTOMER COMPLAINT, WE COULD CONFIRM THE ISSUE STATED BY THE CUSTOMER AS A COMPONENT/SUPPLIER ISSUE. REVIEW OF DHR WAS PERFORMED AND NO ISSUES STATED BY THE CUSTOMER WERE FOUND. INVESTIGATION CONCLUSION: 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 CONSIDERED AS A SUPPLIER ISSUE, A NOTIFICATION AND/OR ALERT WILL BE SENT TO THE SUPPLIER TO FOLLOW UP WITH THEM ON THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING USE A BD CORNWALL¿ DISPOSABLE SYRINGE FILLING SYSTEM WITH TUBING SET WAS FOUND LEAKING FROM THE SYRINGE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165594 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