MAUDE Adverse Event Report: JMS SINGAPORE PTE LTD WINGEATER A. V. FISTULA 15G X 1" BE WITH CLAMP; FISTULA NEEDLE

Model Number	820-5002-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
An area technical operations manager (atom) reported that a hemodialysis patient experienced hemolysis event.Upon follow up, the hemolysis event appears to have occurred between (b)(6) 2019.The patient's pre-hemodialysis treatment labs were drawn on (b)(6) 2019 without any reported issues with the lab specimen.On 06/19/2019, the clinic manager reviewed the lab results which were drawn post hemodialysis treatment and noticed the patient had a drop in their baseline hemoglobin from 10.5 to 9.3.The patient was admitted to the hospital on (b)(6) 2019 and required a blood transfusion.The patient was discharged (b)(6) 2019.Further details regarding the patient's hospitalization are currently unknown.Reportedly, the patient continues to receive hemodialysis treatments.It was reported there was nothing unusual in any of the hemodialysis treatments.This was brought to our attention on 08/19/2019 and as of (b)(6) 2019 no cause of hemolysis was determined.

• Brand Name: WINGEATER A. V. FISTULA 15G X 1" BE WITH CLAMP
• Common Device Name: FISTULA NEEDLE
• Manufacturer (Section D): JMS SINGAPORE PTE LTD; 440 ang mo kio; industrial park 1; singapore, 56962 0; SN 569620
• MDR Report Key: 9013894
• Report Number: 2954317-2019-00001
• Device Sequence Number: 14056114
• Product Code: FIE
• UDI-Device Identifier: 08888483005291
• UDI-Public: 08888483005291
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/12/2019
• Report Date (Section F): 09/12/2019

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: 11/12/2023
• Device Model Number: 820-5002-33
• Device Lot Number: 181112351
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/19/2019
• Device Age: 7 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2019
• 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: Hospitalization
• Patient Age: 49 YR
• Patient Weight: 91
• Date Report Sent to FDA: 09/12/2019