BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-WAY CONNECTING SET 4 SS

    MDR report key: 9990616 · Received April 23, 2020

    Report

    Report Number
    2016493-2020-00536
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    April 2, 2020
    Report Date
    April 2, 2020
    Manufacturer
    DKS LOVERSAN D.O.O.
    Product Code
    LHI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 04/07/2020. INVESTIGATION CONCLUSION: ONE 2305E SAMPLE WAS RECEIVED FOR INVESTIGATION OF COMPLAINT REFERENCE INF-INT-2020-000739. NO PACKAGING WAS RECEIVED WITH THE SAMPLE, HOWEVER THE CUSTOMER HAS INDICATED THAT THE LOT NUMBER IS 1015173. THE SAMPLE WAS RECEIVED WITH RESIDUAL FLUID PRESENT. A VISUAL INSPECTION OF THE SAMPLE DID NOT IDENTIFY ANY LIKELY CAUSE FOR THE CUSTOMER'S EXPERIENCE AND PRESSURE TESTING FOUND NO LEAKAGE FROM ANY JOINT OR COMPONENT . IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE IN THIS INSTANCE AS TESTING OF THE RETURNED SAMPLE DID NOT REPLICATE THE REPORTED LEAKAGE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1015173 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. NO MANUFACTURING DEFECTS WERE IDENTIFIED TO THE RETURNED SAMPLE AND THEREFORE IT WAS NOT POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE; HOWEVER, A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS AN ISOLATED FEEDBACK AGAINST THE 2305E PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 MULTI-WAY CONNECTING SETS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY GOT A LEAK AND IT WAS A STOP IN ONE OF THE SMARTSITES. SO THEY COULDN'T GIVE ANY LIQUID. IT WAS IN ONE OF THE SMARTSITES THAT THE STOP WAS IN. THEY DID NOT PROVIDE ANY CYTOSTATICS IN THE SET. THEY ONLY FILLED IT WITH NACL (SALT WATER).

    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 6 MULTI-WAY CONNECTING SETS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY GOT A LEAK AND IT WAS A STOP IN ONE OF THE SMARTSITES. SO THEY COULDN'T GIVE ANY LIQUID. IT WAS IN ONE OF THE SMARTSITES THAT THE STOP WAS IN. THEY DID NOT PROVIDE ANY CYTOSTATICS IN THE SET. THEY ONLY FILLED IT WITH NACL (SALT WATER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453102 MULTI-WAY CONNECTING SET 4 SS CONNECTING SET LHI DKS LOVERSAN D.O.O. 1015173

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200402