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
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiopulmonary Arrest (1765); Hemorrhage/Blood Loss/Bleeding (1888); Hypovolemia (2243)
Date of Event	08/08/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Exemption number: e2010016.Jmss (manufacturer) is submitting the report on behalf of jmsna (importer).Our manufacturing process was within control and no abnormality was found on the given product lot.The product lot met all the qa outgoing inspection criteria prior releasing to the market.Based on the results of preserved samples evaluation and dhr analysis, there was no abnormality found on complaint lot.From the information gathered from (b)(4), user facility said that their suspicion might be due to patient movement.Furthermore, the user facility had emphasized there were no product problem as upon inspection of the venous avf needle, it was noted that tape and gauze dressing were still intact on the fistula needle.Hence, this incident is not related to our manufacturing process.
Event or Problem Description
On (b)(6) 2018, a hemodialysis patient was going through a 3 hour hemodialysis treatment that involved venous needle dislodgement, hospitalization and death.Two (2) hours into the scheduled treatment, patient was found to be unresponsive.Pressure was held to cannulation site, and normal saline administered via arterial line.Approximately 1.5l of blood loss.911 were called, cpr was initiated and aed applied which advised no shock.A total of 3 liters of normal saline was administered during resuscitation.The patient was then transported to the hospital via ems, where the patient died.Upon inspection of the venous needle, it was noted that tape and gauze dressing were still intact on the fistula needle.The machine was sequestered and functional test was performed.All required parameters passed.

• 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: 7968150
• Report Number: 3002807350-2018-00006
• Device Sequence Number: 1774049
• Product Code: FIE
• UDI-Device Identifier: 08888483005291
• UDI-Public: 08888483005291
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2018
• Report Date (Section F): 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 04/27/2023
• Device Model Number: 820-5002-33
• Device Lot Number: 180427391
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/28/2018
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/03/2018
• 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; Hospitalization
• Patient Age: 79 YR
• Patient Weight: 73
• Date Report Sent to FDA: 09/19/2018