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	Exsanguination (1841); Loss of consciousness (2418); Blood Loss (2597)
Date of Event	10/27/2018
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.The user facility had emphasized there were no product problem as upon inspection of the venous avf 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 defect.It was noted that 1 piece of tape across wing was no longer on patient's skin and needle but 2 other pieces were intact on skin and on needle.
Event or Problem Description
On (b)(6) 2018, a hemodialysis patient, approximately 45 minutes into a scheduled 4 hour hemodialysis treatment when the dialysis machine alarmed arterial pressure.The patient was found in the hemodialysis chair with venous fistula needle dislodged with the tape intact on wings of the venous fistula needle.A pool of blood was noted below the chair, which continued to the wall behind the chair.Chair was in semi-reclined position.Ebl 300 ml.Patient was unresponsive with erratic respiratory rate.Blood pressure was 112/60, pulse 60.2 liters of normal saline was administered through arterial needle.Patient was placed in trendelenburg position and oxygen of 10 l was applied via nasal cannula.Patient was drowsy but responding to verbal stimuli.Ems was called.One unit of packed red blood cells (prbc) was administered in the er and patient was then discharged home.The patient returned to the facility for his next scheduled hemodialysis appointment 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: 8140757
• Report Number: 3002807350-2018-00009
• Device Sequence Number: 10832127
• Product Code: FIE
• UDI-Device Identifier: 08888483005291
• UDI-Public: 08888483005291
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 11/23/2018

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: 05/31/2023
• Device Model Number: 820-5002-33
• Device Lot Number: 180531361
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/23/2018
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2018
• 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: 62 YR
• Patient Weight: 94