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 Codes	Device Dislodged or Dislocated (2923); Expulsion (2933)
Health Effect - Clinical Codes	Hypovolemia (2243); Loss of consciousness (2418); Blood Loss (2597)
Date of Event	10/20/2018
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.Furthermore, the user facility had emphasized there were no product problem as upon inspection of the venous avf needle, it was noted that tape were still intact on the fistula needle.Hence, this incident is not related to our manufacturing process.Nonetheless, briefing was conducted to relevant operators and inspectors for their awareness on the reported complaint.
Event or Problem Description
On (b)(6) 2018, a hemodialysis patient, approximately 2.5 hours in a scheduled 4 hour hemodialysis treatment when the dialysis machine alarmed.The patient was found in the hemodialysis chair with her eyes closed and venous fistula needle was noted be to be dislodged with the tape intact.Blood was pumping out of the venous needle; a pool of blood was noted under the chair approximately the size of the chair.The blood pump was stopped immediately, and normal saline was administered via the arterial fistula needle.Approximately 400ml normal saline bolus, the patient opened her eyes to verbal instruction.911 were called.A total of 1.4 liter of normal saline was administered.Ems with a b/p of 126/961 was discharged on patient.Upon admission to emergency room, her systolic blood pressure was in the 70's and she was bradycardic.1 liter of fluid and 2 units packed red blood cells (prbc) was infused on the patient.She was admitted to the icu for hemorrhagic shock and discharged from the hospital on (b)(6) 2018, returning for here next scheduled in-center hemodialysis treatment on (b)(6) 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: 8140758
• Report Number: 3002807350-2018-00008
• Device Sequence Number: 13848521
• Product Code: FIE
• UDI-Device Identifier: 08888483005291
• UDI-Public: 08888483005291
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Report Date (Section B): 11/27/2018
• Report Date (Section F): 11/01/2018

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: No Information
• Device Expiration Date: 06/18/2023
• Device Model Number: 820-5002-33
• Device Lot Number: 180618371
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/15/2018
• Device Age: 5 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2018
• 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: 66 YR
• Patient Weight: 119