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

Device Problems Backflow (1064); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypovolemia (2243); Loss of consciousness (2418); Blood Loss (2597)

Event Date 11/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 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
• Type of Device: JMS SYSLOC MINI A.V. FISTULA NEEDLE SET
• Manufacturer (Section D): JMS SINGAPORE PTE LTD; jms singapore pte ltd; singapore, 56962 0; SN 569620
• Manufacturer (Section G): PT. JMS BATAM; lot 211 jalan beringin; batmindo ind.park muka kuning; indonesia, ; ID
• Manufacturer Contact: chin yin ; 440 ang mo kio industrial pk 1; singapore, 56962-0 ; SN 569620
• MDR Report Key: 8243170
• MDR Text Key: 132922615
• Report Number: 3002807350-2018-00011
• Device Sequence Number: 1
• Product Code: FIE
• UDI-Device Identifier: 08888483005567
• UDI-Public: 08888483005567
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/24/2018,11/29/2018

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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/24/2018
• Initial Date FDA Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 66