MAUDE Adverse Event Report: JMS SINGAPORE PTE LTD SYSLOC MINI AVF 1 5GX1" BE 30CM W/CLAMP; JMS SYSLOC MINI A.V. FISTULA NEEDLE SET

Model Number	864-1500-33
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Exsanguination (1841); Hypovolemia (2243); Blood Loss (2597)
Date of Event	11/27/2018
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 for reported lot 180830331.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 (b)(4), 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, arrived to treatment; pre-dialysis vs obtained b/p 153/77; pulse 86; resp 17; temp 97.8.Approximately 2 hours into the scheduled 4 hour hemodialysis treatment vs obtained were: b/p 97/52; pulse 84.The ultrafiltration was turned off and the patient's legs were elevated.The machine subsequently alarmed venous pressure and the blood pump stopped.The patient was lethargic and slow to respond verbally with the venous needle dislodged with the tape intact on the wings of the needle.Blood was noted to be flowing down the inside of the chair; a puddle of blood was under the chair.Estimated blood loss (ebl) was 1 unit.Approximately 400 mls normal saline was administered.Ems was called.Upon discharge from the facility via ems, patient was oriented with b/p 102/64; pulse 118.The patient was admitted to the hospital.1 unit of pack red blood cells (prbcs) was infused in the er.

• Brand Name: SYSLOC MINI AVF 1 5GX1" BE 30CM W/CLAMP
• Common Device Name: JMS SYSLOC MINI 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: 8243182
• Report Number: 3002807350-2018-00012
• Device Sequence Number: 11378292
• Product Code: FIE
• UDI-Device Identifier: 08888483005567
• UDI-Public: 08888483005567
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/06/2018
• 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: 08/30/2023
• Device Model Number: 864-1500-33
• Device Lot Number: 180830331
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/24/2018
• Device Age: 4 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: Not provided
• Initial Report FDA Received Date: 01/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 77 YR
• Patient Weight: 80