MAUDE Adverse Event Report: JMS SINGAPORE PTE LTD WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP; JMS WINGEATER A.V.FISTULA NEEDLE SET

Model Number	820-5002-33
Health Effect - Clinical Codes	Death (1802); Blood Loss (2597)
Date of Event	01/06/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Exemption number: e2010016.Jmss (manufacturer) is submitting the report on behalf of jmsna (importer).Although we have established that the device did not caused or contributed to the event, we are reporting it out of caution to be in compliance with 21 cfr part 803 related to death case.Based on our reserve sample evaluation and device history record of the lot numbers on 3 month frame to customer from 10 jan 2017 to 01 jun 2018, there was no abnormality found.The products met the qa specifications prior releasing it to the market.There was no reported or detected malfunction on the needle itself.Due to unavailability of actual sample involved in the event, we are unable to verify the actual cause of the reported claim.We did due diligence and investigated the lot numbers on 3 month frame to customer from 10 jan 2017 to 01 jun 2018, in an effort to further substantiate that there is no abnormality observed in our products.Based on the information provided by initial reporter, there was no abnormality on the needle set.The internal investigation into suspected cause was inconclusive as there were no product problem.
Event or Problem Description
With reference to (b)(6) fda letter.Pdf, on (b)(6) 2018, a hemodialysis (hd) patient completed a scheduled hd treatment without any issues but was later found bleeding in her car and subsequently expired.Follow-up information obtained via phone call with the clinic manager that the patient had no issues during or after treatment.There were no allegations of any hd device or product malfunction.The patient was discharged to home following treatment, where she drives to the clinic by herself.The patient left the clinic around 1015 without any known issue with her fistula.It was unknown what the patient had done after she left the clinic.It was very cold outside that day and the patient was wearing a heavy jacket.At some time while driving out her car after treatment, the patient noticed blood leaking from her fistula and pulled over and stopped to call ems.The source of blood loss was from her av fistula (right upper/brachial basilic).Emergency team found her and took her to the hospital but she expired that day.It was not known whether patient expired in her car or while in route or while in hospital.It was reported in the facility's adverse event form that there was poor healing of the needle sites (scabbing) regarding the patient's fistula.There have been no errors or issues with anticoagulant therapy during treatment prior to the event.The patient does not have a history of any bleeding disorders.
Additional Manufacturer Narrative
Exemption number: (b)(4).Jmss (manufacturer) is submitting the report on behalf of (b)(4).Although we have established that the device did not caused or contributed to the event, we are reporting it out of caution to be in compliance with 21 cfr part 803 related to death case.Based on our reserve sample evaluation and device history record of the lot numbers on 3 month frame to customer from (b)(6) 2017 to (b)(6) 2018, there was no abnormality found.The products met the qa specifications prior releasing it to the market.There was no reported or detected malfunction on the needle itself.Due to unavailability of actual sample involved in the event, we are unable to verify the actual cause of the reported claim.We did due diligence and investigated the lot numbers on 3 month frame to customer from (b)(6) 2017 to (b)(6) 2018, in an effort to further substantiate that there is no abnormality observed in our products.Based on the information provided by initial reporter, there was no abnormality on the needle set.The internal investigation into suspected cause was inconclusive as there were no product problem.This submission has been resubmitted due to revised under manufacture narrative, device history record of the lot numbers on 3 month frame to customer from "10 jan 2017 to 01 jun 2018" to "01 oct 2017 to 06 jan 2018".
Event or Problem Description
With reference to (b)(4) on (b)(6) 2018, a hemodialysis (hd) patient completed a scheduled hd treatment without any issues but was later found bleeding in her car and subsequently expired.Follow-up information obtained via phone call with the clinic manager that the patient had no issues during or after treatment.There were no allegations of any hd device or product malfunction.The patient was discharged to home following treatment, where she drives to the clinic by herself.The patient left the clinic around 1015 without any known issue with her fistula.It was unknown what the patient had done after she left the clinic.It was very cold outside that day and the patient was wearing a heavy jacket.At some time while driving out her car after treatment, the patient noticed blood leaking from her fistula and pulled over and stopped to call ems.The source of blood loss was from her av fistula (right upper/brachial basilic).Emergency team found her and took her to the hospital but she expired that day.It was not known whether patient expired in her car or while in route or while in hospital.It was reported in the facility's adverse event form that there was poor healing of the needle sites (scabbing) regarding the patient's fistula.There have been no errors or issues with anticoagulant therapy during treatment prior to the event.The patient does not have a history of any bleeding disorders.

• Brand Name: WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP
• Common Device Name: JMS WINGEATER A.V.FISTULA NEEDLE SET
• Manufacturer (Section D): JMS SINGAPORE PTE LTD; 440 ang mo kio industrial pk 1; singapore, 56962 0; SN 569620
• MDR Report Key: 7312367
• Report Number: 3002807350-2018-00002
• Device Sequence Number: 1249451
• Product Code: FIE
• UDI-Device Identifier: 08888483005291
• UDI-Public: 08888483005291
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K111948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 820-5002-33
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/08/2018
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 03/04/2018
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Weight: 111