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
Health Effect - Clinical Code	Death (1802)
Date of Event	03/09/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Exemption number: e2010016.Jmss (manufacturer) is submitting the report on behalf of (b)(4).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 related to death case.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 inconclusive as there were no product problems.
Event or Problem Description
The donor center contacted the distributors and importers to inquire if there were any manufacturing issues for disposable soft-goods they had been using because there was a fatality of a donor.On (b)(6) 2018, donor suffered from a suspected massive heart attack after completed a successful donation a day before ((b)(6) 2018).Fatality detail was suspected massive heart attack (reported by relative).Donor's date of first donation was in (b)(6) 2013.Donor's donation history he was a qualified donor.He had donated a total of 316 donations.There was no unusual history medical or vitals.There was no adverse event reported for last donation on (b)(6) 2018.
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 related to death case.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 inconclusive as there were no product problems.
Event or Problem Description
The donor center contacted the distributors and importers to inquire if there were any manufacturing issues for disposable soft-goods they had been using because there was a fatality of a donor.On (b)(6) 2018, donor suffered from a suspected massive heart attack after completed a successful donation a day before ((b)(6) 2018).Fatality detail was suspected massive heart attack (reported by relative).Donor's date of first donation was in (b)(6) 2013.Donor's donation history: he was a qualified donor.He had donated a total of 316 donations.There was no unusual history medical or vitals.There was no adverse event reported for last donation on (b)(6) 2018.

• 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: 7368995
• Report Number: 3002807350-2018-00003
• Device Sequence Number: 1633400
• Product Code: FIE
• UDI-Device Identifier: 08888483005390
• UDI-Public: 08888483005390
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2022
• Device Model Number: 820-7005-33
• Device Lot Number: 170808391
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2018
• Device Age: 7 MO
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 03/26/2018
• 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: 50 YR
• Patient Weight: 75