MAUDE Adverse Event Report: JMS SINGAPORE PTE LTD WINGEATER A.V.FISTULA 17GX11/4" BE 30CM W/CLAMP; JMS WINGEATER A.V.FISTULA NEEDLE SET

Model Number	820-7005-33
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
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 cause or contribute to the event, we are reporting it out of caution to be in compliance with 21 cfr part 803 due to the medical intervention of 600ml saline bonus administered on patient and the transfer of patient to the emergency room.Jmss did due diligence and conducted an investigation as a precaution if the device contributed to the adverse event.Based on our reserve sample evaluation and device history record of the lot number provided by the clinic, 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.Although we could not establish causal effect (either use error or product defect), we did due diligence and investigated the reported lot, 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 due to cross-threading of the tubings as there were no product problems.From the product pamphlet, instruction for use (ifu) that accompanies the device, end-user is cautioned to firmly join the connectors to each other.All connections must be checked carefully prior to and during the first minutes of operation.During treatment, connections must be visually inspected periodically to detect leaks and avoid blood loss.
Event or Problem Description
It was reported that the arterial needle separated from the extracorporeal system mid-hemodialysis treatment resulting in significant blood loss from the patient.Addendum 21 mar 2018: patient had received 500ml normal saline and was transported to the emergency room but was stable upon arrival.Patient was monitored and was released at the same day.

• Brand Name: WINGEATER A.V.FISTULA 17GX11/4" 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: 7424160
• Report Number: 3002807350-2018-00004
• Device Sequence Number: 1633396
• Product Code: FIE
• UDI-Device Identifier: 08888483005390
• UDI-Public: 08888483005390
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 04/04/2018

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 Expiration Date: 08/11/2021
• Device Model Number: 820-7005-33
• Device Lot Number: 170811371
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2018
• Device Age: 9 MO
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/11/2018
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 80