BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVF WINGEATER NEEDLE

    MDR report key: 3596038 · Received January 28, 2014

    Report

    Report Number
    3002807350-2014-00001
    Event Type
    Injury
    Date Received
    January 28, 2014
    Report Date
    February 21, 2014
    Manufacturer
    JMS SINGAPORE PTE LTD
    Product Code
    FIE
    PMA / PMN Number
    K111948
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JMSS (THE MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4) (THE IMPORTER)". 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. DUE TO UNAVAILABILITY OF SAMPLE INVOLVED IN THE EVENT, WE ARE UNABLE TO DETERMINE THE ACTUAL CAUSE OF DEFECT. BASED ON EVALUATION RESULTS OF THE INVESTIGATION CARRIED OUT, CAUSE OF THE REPORTED EVENT WAS UNLIKELY TO BE RELATED TO JMSS AS THE MANUFACTURING PROCESS WAS WITHIN CONTROL. BASED ON VARIOUS SIMULATION TESTS CONDUCTED, ALTHOUGH IT WAS POSSIBLE TO MANUFACTURE PRODUCTS WITH NEEDLES THAT DO NOT MEET THE QA SPECIFICATION, SUCH PRODUCTS WOULD BE DETECTED AND SCREENED OUT WITHIN OUR MANUFACTURING PROCESS THROUGH VARIOUS INSPECTION STATIONS. MOREOVER, THE OPERATORS AND INSPECTORS IN MANUFACTURING PROCESS ARE TRAINED TO WORK ACCORDING TO THE DOCUMENTED SOP'S. THUS, THE REPORTED DEFECT IS UNLIKELY TO BE CAUSED BY JMSS MANUFACTURING PROCESS. BASED ON PAST 10 YEARS COMPLAINT DATABASE AND INTERNAL QUALITY REPORT, WE HAVE NEVER ENCOUNTERED SUCH DEFECT INTERNALLY AND FROM THE MARKET ON THE REPORTED DEFECT. (B)(4). MOREOVER, BASED ON USER FACILITY'S FOLLOW-UP REPORT, NOTHING UNUSUAL WAS OBSERVED DURING PATIENT'S DIALYSIS IN THEIR FACILITY. ALSO, THEY WERE UNABLE TO CONFIRM WHETHER OR NOT THE NEEDLE EXTRACTED FROM THE PATIENT IS A JMS BRAND NEEDLE. LASTLY, JMS WILL CONTINUE TO MAINTAIN GOOD QUALITY OF OUR PRODUCTS AND ENSURE ONLY GOOD QUALITY PRODUCTS ARE DELIVERED TO OUR CUSTOMERS.

    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. THIS MDR WAS BROUGHT UP BY THE USER FACILITY ((B)(6) DIALYSIS CENTER) WHEN THEY HEARD FROM (B)(6) HOSPITAL THAT A NEEDLE WAS REMOVED FROM THEIR DIALYSIS PATIENT. THE USER FACILITY INFORMED US THAT THEY WERE NOT ABLE TO CONFIRM THAT IT WAS A JMS NEEDLE. WE HAVE STARTED THE INVESTIGATION AND CONTACTED (B)(6) DIALYSIS CENTER AND (B)(6) HOSPITAL FOR MORE DETAILED INFORMATION ON THE INCIDENT. FROM THE INFORMATION AND THE PICTURE THAT WAS PROVIDED TO US BY (B)(6) DIALYSIS CENTRE AND (B)(6) HOSPITAL, WE ARE NOT ABLE TO DETERMINE IF THE NEEDLE WAS MANUFACTURED BY JMS. MOREOVER, DUE TO UNAVAILABILITY OF LOT NUMBER PROVIDED, WE ARE UNABLE TO DO A MORE THOROUGH INVESTIGATION. HOWEVER, BASED ON THE PICTURE OF THE NEEDLE PROVIDED BY THE HOSPITAL, WE DID OUR DUE DILIGENCE BY CONDUCTING A MORE THOROUGH INVESTIGATION ASSUMING IT AS JMS MANUFACTURED NEEDLE. BASED ON USER FACILITY'S FOLLOW-UP REPORT (DATED 11-JAN-14), NOTHING UNUSUAL WAS OBSERVED DURING PATIENT'S DIALYSIS IN THEIR FACILITY. ALSO, THEY WERE UNABLE TO CONFIRM WHETHER OR NOT THE NEEDLE EXTRACTED FROM THE PATIENT IS A JMS WINGEATER AV FISTULA NEEDLE. HOWEVER, WE HAVE CONDUCTED VARIOUS SIMULATIONS AND INTERNAL INVESTIGATIONS TO DETERMINE IF SUCH INCIDENT WAS POSSIBLE. FROM THE RESULTS OF SIMULATIONS WE HAVE CONDUCTED, THE CHANCE OF SUCH INCIDENT OCCURRING WITH JMS NEEDLE IS VERY UNLIKELY. BASED ON OUR IN-DEPTH INVESTIGATION, WE COULD NOT IDENTIFY ANY ROOT CAUSE ON THE REPORTED INCIDENT. THUS, THE REPORTED INCIDENT IS UNLIKELY TO OCCUR DUE TO JMSS MANUFACTURING PROCESS. LASTLY, JMS WILL CONTINUE TO MAINTAIN GOOD QUALITY OF OUR PRODUCTS AND ENSURE ONLY GOOD QUALITY PRODUCTS ARE DELIVERED TO OUR CUSTOMERS.

    Description of Event or Problem · 1

    (B)(6) REPORTED THAT THEY RECEIVED A CALL FROM (B)(6) THAT ON (B)(6) 2013, PATIENT WAS SEEN BY THE VASCULAR SERVICE FOR COMPLAINT OF PERSISTENT LEFT SHOULDER PAIN. IMAGING INDICATED A NEEDLE-SHAPED OBJECT IN THE RIGHT ATRIUM. SURGICAL EXPLORATION FOUND THE NEEDLE IN THE RIGHT VENTRICLE WHICH WAS RETRIEVED THROUGH THE TRICUSPID VALVE WITHOUT COMPLICATION. NO PUNCTURE OR LACERATION WOUNDS WERE FOUND. THE PROCEDURE WAS UNEVENTFUL AND THE PATIENT WAS IN RECOVERY. NEEDLE WAS SUBMITTED TO PATHOLOGY. PATIENT BEEN DIALYZED IN THE FACILITY SINCE YEAR 2012. SERIAL NUMBER, LOT NUMBER AND EXPIRATION DATE OF THIS IDENTIFIED JMS NEEDLE IS UNKNOWN. ON (B)(6) 2013, A NOTE FROM INTERVENTIONALIST STATED THERE IS NO OBVIOUS FOREIGN BODY SEEN IN THE SUBCLAVIAN, BRACHIOCEPHALIC VEINS OF SUPERIOR VENA CAVA. THERE IS NO SIGN OF FOREIGN BODY IN THE HEART OR PULMONARY ARTERIES. DATED (B)(6) 2014, USER FACILITY ADDED IN THEIR INITIAL REPORT THAT THERE WAS NOTHING UNUSUAL OBSERVED DURING THE PATIENT'S DIALYSIS IN THE FACILITY. AT THIS POINT OF TIME, THE USER FACILITY IS UNABLE TO CONFIRM WHETHER OR NOT THE NEEDLE EXTRACTED FROM THE PATIENT'S HEART IS A JMS WINGEATER NEEDLE.

    Description of Event or Problem · 1

    (B)(6) DIALYSIS CENTRE REPORTED THAT THEY RECEIVED A CALL FROM (B)(6) THAT ON (B)(6) 2013, PATIENT WAS SEEN BY THE VASCULAR SERVICE FOR COMPLAINT OF PERSISTENT LEFT SHOULDER PAIN. IMAGING INDICATED A NEEDLE-SHAPED OBJECT IN THE RIGHT ATRIUM. SURGICAL EXPLORATION FOUND THE NEEDLE IN THE RIGHT VENTRICLE WHICH WAS RETRIEVED THROUGH THE TRICUSPID VALVE WITHOUT COMPLICATION. NO PUNCTURE OR LACERATION WOUNDS WERE FOUND. THE PROCEDURE WAS UNEVENTFUL AND THE PATIENT WAS IN RECOVERY. NEEDLE WAS SUBMITTED TO PATHOLOGY. PATIENT BEEN DIALYZED IN THE FACILITY SINCE YEAR 2012. SERIAL NUMBER, LOT NUMBER AND EXPIRATION DATE OF THIS IDENTIFIED JMS NEEDLE IS UNKNOWN. ON 17-SEP-13, A NOTE FROM INTERVENTIONALIST STATED THERE IS NO OBVIOUS FOREIGN BODY SEEN IN THE SUBCLAVIAN, BRACHIOCEPHALIC VEINS OF SUPERIOR VENA CAVA. THERE IS NO SIGN OF FOREIGN BODY IN THE HEART OR PULMONARY ARTERIES. DATED 11-JAN-14, USER FACILITY ADDED IN THEIR INITIAL REPORT THAT THERE WAS NOTHING UNUSUAL OBSERVED DURING THE PATIENT'S DIALYSIS IN THE FACILITY. AT THIS POINT OF TIME, THE USER FACILITY IS UNABLE TO CONFIRM WHETHER OR NOT THE NEEDLE EXTRACTED FROM THE PATIENT'S HEART IS A JMS WINGEATER NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61215 AVF WINGEATER NEEDLE FOZ, FIE FIE JMS SINGAPORE PTE LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R