MAUDE Adverse Event Report: JMS SINGAPORE PTE LTD SYSLOC MINI AVF 15GX1" BE 30CM W/CLAMP; JMS SYSLOC MINI A.V. FISTULA NEEDLE SET

Model Number	864-1500-33
Medical Device Problem Codes	Backflow (1064); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypovolemia (2243); Loss of consciousness (2418); Blood Loss (2597)
Date of Event	11/23/2018
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 reported lot 180608332.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 the information provided by facility and jmsna, no defect or malfunction was observed of the jms sysloc mini avf.Hence, this incident is not related to our manufacturing process.Nonetheless, briefing was conducted on 26 dec 2018 to all related operators and inspectors for their awareness on the reported defect.(b)(4).
Event or Problem Description
On (b)(6) 2018, a hemodialysis patient, approximately 45 minutes into a scheduled 3.5 hour hemodialysis treatment, the venous fistula needle was found to be leaking blood around the cannulation site.Staff reported venous needle was partially dislodged.The tape was intact on the wings of the fistula needle and secured to the patient.The patient was unresponsive to verbal commands.Vs: b/p: 79/39, pulse: 104.Blood was partially returned via the venous fistula needle.The venous cannulation site infiltrated and the remaining blood was returned via the arterial fistula needle.Approximately 800 mls normal saline was administered.Ems was called.Upon discharge from the facility via ems, b/p was 101/69, pulse 100, resp 18.The patient was awake and alert upon discharge.He was admitted to the hospital.2 units of packed red blood cells (prbcs) were infused.The patient returned to the facility for hemodialysis on (b)(6) 2018.

• Brand Name: SYSLOC MINI AVF 15GX1" BE 30CM W/CLAMP
• Common Device Name: JMS SYSLOC MINI A.V. FISTULA NEEDLE SET
• Manufacturer (Section D): JMS SINGAPORE PTE LTD; jms singapore pte ltd; singapore, 56962 0; SN 569620
• MDR Report Key: 8243170
• Report Number: 3002807350-2018-00011
• Device Sequence Number: 2389198
• Product Code: FIE
• UDI-Device Identifier: 08888483005567
• UDI-Public: 08888483005567
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142564
• 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
• Report Date (Section B): 11/29/2018
• Report Date (Section F): 12/24/2018

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: 06/08/2023
• Device Model Number: 864-1500-33
• Device Lot Number: 180608332
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/24/2018
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2018
• Initial Report FDA Received Date: 01/14/2019
• 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: 59 YR
• Patient Weight: 66