MAUDE Adverse Event Report: JMS SINGAPORE PTE LTD WINGEATER A.V. FISTULA 15G X1" 30CM W/CLAMP; JMS WINGEATER A.V. FISTULA NEEDLE SET

Model Number	820-5002-33
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243); Blood Loss (2597)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 for reported lot 180804361.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.As per information provided by facility and jmsna, there were no product problems found on venous needle at any time.Hence, this incident is not related to our manufacturing process.Nonetheless, briefing was conducted on 21 jan 2019 on all related operators and inspectors for their awareness on the reported defect.
Event or Problem Description
On (b)(6) 2018, a hemodialysis patient, (age: (b)(6), gender: female; estimated dry weight: (b)(6)), arrived to treatment alert and oriented.Pre-dialysis vital signs obtained: b/p: 187/62; pulse 72; resp 18; temp: 98.0.At 19:59, the patient was observed with access covered and no bleeding from site.At 20:01, approximately 2.5 hours into scheduled 4 hour hemodialysis treatment during the q 30 minute vital signs check, the patient was noted to be slow to respond.Vs obtained: b/p 47/26; pulse 64.Patient's venous needle was dislodged with tape intact on the wings of the needle.Large amount of blood was noted on both the chair and the floor.Ebl 500ml.The venous line was clamped and pressure applied to the venous cannulation site.Normal saline was administered via the arterial needle.911 was called.After infusion of approximately 1000ml normal saline, b/p: 126/53; pulse 64; patient was alert and oriented.Upon discharge from the facility via ems, the patient was alert and oriented with b/p 110/50; pulse 67; resp 18.The patient was transported to the hospital and admitted.The patient returned to the facility for hemodialysis on (b)(6) 2018.
Additional Manufacturer Narrative
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 for reported lot: 180804361.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.As per information provided by facility and jmsna, there were no product problems found on venous needle at any time.Hence, this incident is not related to our manufacturing process.Nonetheless, briefing was conducted on 21 jan 2019 on all related operators and inspectors for their awareness on the reported defect.
Event or Problem Description
On (b)(6) 2018, a hemodialysis patient, (age: 69, gender: female; estimated dry weight: 88kg), arrived to treatment alert and oriented.Pre-dialysis vital signs obtained: b/p: 187/62; pulse 72; resp 18; temp: 98.0.At 19:59, the patient was observed with access covered and no bleeding from site.At 20:01, approximately 2.5 hours into scheduled 4 hour hemodialysis treatment during the q 30 minute vital signs check, the patient was noted to be slow to respond.Vs obtained: b/p 47/26; pulse 64.Patient's venous needle was dislodged with tape intact on the wings of the needle.Large amount of blood was noted on both the chair and the floor.Ebl 500ml.The venous line was clamped and pressure applied to the venous cannulation site.Normal saline was administered via the arterial needle.911 was called.After infusion of approximately 1000ml normal saline, b/p: 126/53; pulse 64; patient was alert and oriented.Upon discharge from the facility via ems, the patient was alert and oriented with b/p 110/50; pulse 67; resp 18.The patient was transported to the hospital and admitted.The patient returned to the facility for hemodialysis on (b)(6) 2018.

• Brand Name: WINGEATER A.V. FISTULA 15G X1" 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: 8319395
• Report Number: 3002807350-2019-00002
• Device Sequence Number: 13782633
• Product Code: FIE
• UDI-Device Identifier: 08888483005307
• UDI-Public: 08888483005307
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019
• Report Date (Section F): 01/04/2019

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: 04/08/2023
• Device Model Number: 820-5002-33
• Device Lot Number: 180804361
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/21/2019
• Device Age: 5 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 02/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR
• Patient Weight: 88