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 Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Exsanguination (1841); Dizziness (2194); Hypovolemia (2243)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
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 reserved samples evaluation and dhr analysis, there was no abnormality found on complaint lot.Investigation was carried out based on the lot 180519391 and 180622391.Based on the results of dhr analysis and reserve samples evaluation, there was no abnormality found on the reported product lot.We would like to emphasize that our manufacturing process was within control and all our products met the jms qa outgoing inspection criteria prior to market release.The user facility pct did not report any problems with luers when pct tightened the connection administering normal saline and continue to return the blood.The clinical manager reported that the leak was due to a loose connection and suspects that the luer connector was not tightened properly during setup.Nonetheless, briefing was conducted on (b)(4) 2018 to all related operators and inspectors for their awareness on the reported adverse event.
Event or Problem Description
A hemodialysis patient scheduled 3.75 hour hemodialysis treatment was initiated at 11:40am.B/p 122/73, pulse 92.At 12:26, b/p was 103/43, pulse 89; 300 ml normal saline was administered.Normal saline was administered over the next 2 hours for hypotension, totaling 1700ml.When discontinuing treatment at 14:32, the pct picked up the venous bloodline and noted it was not securely tightened to the fistula needle and was leaking blood.The pct tightened the connection to administered normal saline and continue to return the blood.Blood was noted on the floor; no blood was noted on the front of the patient, chair, or chairside table.It appeared blood was dripping on the outside of his arm to the floor.600ml normal saline was administered.Patient did not lose consciousness at any time.Ems was called and the patient was transported to the hospital and admitted.Upon discharge the dialysis facility, the patient was awake and alert, and b/p was 114/48; pulse 89; resp 17; temp 97.5.Patient received 3 units of packed red blood cells (prbcs) during the hospitalization.He was discharged from the hospital (b)(6) 2018, returning for hemodialysis on (b)(6) 2018.
Event or Problem Description
A hemodialysis patient scheduled 3.75 hour hemodialysis treatment was initiated at 11:40am.B/p 122/73, pulse 92.At 12:26, b/p was 103/43, pulse 89; 300 ml normal saline was administered.Normal saline was administered over the next 2 hours for hypotension, totaling 1700ml.When discontinuing treatment at 14:32, the pct picked up the venous bloodline and noted it was not securely tightened to the fistula needle and was leaking blood.The pct tightened the connection to administered normal saline and continue to return the blood.Blood was noted on the floor; no blood was noted on the front of the patient, chair, or chairside table.It appeared blood was dripping on the outside of his arm to the floor.600ml normal saline was administered.Patient did not lose consciousness at any time.Ems was called and the patient was transported to the hospital and admitted.Upon discharge the dialysis facility, the patient was awake and alert, and b/p was 114/48; pulse 89; resp 17; temp 97.5.Patient received 3 units of packed red blood cells (prbcs) during the hospitalization.He was discharged from the hospital on (b)(6) 2018, returning for hemodialysis on (b)(6) 2018.
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 reserved samples evaluation and dhr analysis, there was no abnormality found on complaint lot.Investigation was carried out based on the lot: 180519391 and 180622391.Based on the results of dhr analysis and reserve samples evaluation, there was no abnormality found on the reported product lot.We would like to emphasize that our manufacturing process was within control and all our products met the jms qa outgoing inspection criteria prior to market release.The user facility pct did not report any problems with luers when pct tightened the connection administering normal saline and continue to return the blood.The clinical manager reported that the leak was due to a loose connection and suspects that the luer connector was not tightened properly during setup.Nonetheless, briefing was conducted on 5th dec 2018 to all related operators and inspectors for their awareness on the reported adverse event.This submission has been resubmitted due to lot#.Date recieved by manufacturer changed from 12-apr-2018 to 04-dec-2018.

• 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: 8182752
• Report Number: 3002807350-2018-00010
• Device Sequence Number: 19237669
• Product Code: FIE
• UDI-Device Identifier: 08888483005291
• UDI-Public: 08888483005291
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018
• Report Date (Section F): 11/14/2018

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: 06/22/2018
• Device Model Number: 820-5002-33
• Device Lot Number: 180622391
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/04/2018
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 12/20/2018
• 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: Hospitalization
• Patient Age: 59 YR
• Patient Weight: 102