MAUDE Adverse Event Report: JMS SINGAPORE PTE LTD WINGEATER A.V.FISTULA 17G X 11/4" BE 30CM W/CLAMP; FISTULA NEEDLE

Model Number	820-7005-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Myocardial Infarction (1969)
Date of Event	03/06/2017
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 cause or contribute to the event, we are reporting it out of caution to be in compliance with 21cfr part 803 due to the fatal incident.Based on the information provided by donor center, there was no record of any of the products/ lots used during donation having had any defects or noted issues.Medical department from donor center had determined that the fatality was unrelated to the donation.Jms wingeater a.V.Fistula needle was only associated with the event.From reserve sample evaluation and device history record review, there was no abnormality found on the reported lot number.The products met the qa specifications prior releasing it to the market.There was no malfunction on the needle itself.Lastly, jms will continue to maintain good quality of our products and ensure that only good quality products are delivered to customers.We will continue to work with our customers to improve our products quality.Not returned to manufacturer.
Event or Problem Description
Donor experienced a heart attack which proved fatal following a donation at the facility, (b)(6) on (b)(6) 2017.The center did not have any record for the products/ lots used during donation having any defects or noted issues.As part of their investigation, the center was requesting documentation from the soft goods manufacturer if there is any issue with the lots of items used during the donor's donation.The actual jms needle had been disposed.

• Brand Name: WINGEATER A.V.FISTULA 17G X 11/4" BE 30CM W/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: 6459236
• Report Number: 3002807350-2017-00001
• Device Sequence Number: 621713
• Product Code: FIE
• UDI-Device Identifier: 08888483005390
• UDI-Public: 08888483005390
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K111948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2017
• Report Date (Section F): 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Phlebotomist
• Device Expiration Date: 11/02/2021
• Device Model Number: 820-7005-33
• Device Lot Number: 161103381
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/15/2017
• Device Age: 4 MO
• Event Location: Other
• Date Report to Manufacturer: 03/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 04/04/2017
• 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: 51 YR
• Patient Weight: 87