BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSLOC MINI AVF 15G X 1" BE 30CM /CLAMP

    MDR report key: 3840044 · Received May 30, 2014

    Report

    Report Number
    3002807350-2014-00004
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    April 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    JMS SINGAPORE PTE LTD
    Product Code
    FIE
    PMA / PMN Number
    K110157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE ARE REPORTING IT OUT OF CAUTION TO BE IN COMPLIANCE WITH 21CFR PART 803. WE CANNOT RULE OUT CAUSALITY. FROM RESERVE SAMPLE EVALUATION AND DEVICE HISTORY RECORD REVIEW, THERE WAS NO ABNORMALITY FOUND AND THE COMPLAINT LOT MET THE QA SPECIFICATIONS PRIOR RELEASING IT TO THE MARKET. THERE WAS NO MALFUNCTION ON THE NEEDLE ITSELF. AS PER THE DESIGN OF THE DEVICE, THE NEEDLE CANNOT BE RETRACTED INTO THE SAFETY FEATURE (BLUE WING) IF THE EXTERNAL LOCK IS CAPPED. EXTERNAL LOCK IS OPENED ONLY DURING RETRACTION OF THE NEEDLE. IF THE DEFECT IS RELATED TO OUR MANUFACTURING PROCESS, THE INCIDENT COULD HAVE OCCURRED AT THE BEGINNING OR MIDDLE OF THE TREATMENT. BASED ON THE INFORMATION RECEIVED FROM THE CLINIC, THE NEEDLE WAS RETRACTED UPON COMPLETION OF THE ENTIRE TREATMENT AND DURING PREPARATION OF WITHDRAWAL PROCEDURE. BASED ON THE INFORMATION PROVIDED BY THE CLINICAL MANAGER, THE INCIDENT HAPPENED AFTER THE COMPLETION OF THE DIALYSIS TREATMENT. THE POSSIBILITY EXISTS THAT THE PATIENT MIGHT HAVE MOVED OR MIGHT HAVE ACCIDENTALLY OPENED THE EXTERNAL LOCK AT THE END OF THE TREATMENT CAUSING THE NEEDLE TO RETRACT INSIDE THE WING OR THE NEEDLE SET OR BLOOD LINES MIGHT HAVE CAUGHT ON SOMETHING WHICH CAUSED THE EXTERNAL LOCK TO BE OPENED ACCIDENTALLY AND CAUSING THE NEEDLE TO RETRACT INSIDE THE WING. AS INDICATED IN CLAUSE 1.4 IN THIS REPORT, THE FOLLOWING PRECAUTIONARY STATEMENT IS STATED IN OUR INSTRUCTION FOR USE UNDER CLAUSE 4, TO CAUTION USER ON THE CORRECT METHOD OF HANDLING EXTERNAL LOCK "DO NOT UNLOCK THE DEVICE PRIOR TO CANNULATION BECAUSE IT IS DIFFICULT TO LOCK BACK IF IT IS NOT CENTERED PROPERLY. VISUAL INSPECTION OF LOCKING MECHANISM SHOULD BE DONE PRIOR TO CANNULATION. TUG SLIGHTLY ON THE TUBING TO ENSURE THAT THE LOCK IS ENGAGED". THUS, NO CORRECTIVE ACTION WILL BE APPLICABLE AS REPORTED INCIDENT IS NOT RELATED TO ANY MALFUNCTION OF JMSS PRODUCT. (B)(4). JMSS WILL CONTINUE TO MAINTAIN GOOD QUALITY OF OUR PRODUCTS AND ENSURE THAT ONLY GOOD QUALITY PRODUCTS ARE DELIVERED TO CUSTOMERS. SAMPLE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    FACILITY ((B)(6)) REPORTED THROUGH THEIR INITIAL REPORT THAT PATIENT CARE TECHNICIAN (PCT) WAS ATTEMPTING TO PULL VENOUS NEEDLE WHEN ARTERIAL NEEDLE SLID OUT OF THE INSERTION SITE DESPITE STILL BEING TAPED DOWN. PATIENT SUFFERED GREATER THAN 100ML BLOOD LOSS. THE REPORTER PROVIDED ADDITIONAL INFORMATION VERBALLY THAT IT WAS ACTUALLY THE VENOUS NEEDLE RETRACTED INTO WINGS UNEXPECTEDLY, IT WAS TAPED PROPERLY. THE CLINIC STAFF COULD NOT CONFIRM IF THERE WAS ANY DEFECT ON NEEDLE AS THEY DID NOT NOTICE ANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319099 SYSLOC MINI AVF 15G X 1" BE 30CM /CLAMP FIE FIE JMS SINGAPORE PTE LTD 864-1500-33 130916321

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention