JMS WINGEATER SAFETY A-V FISTULA NEEDLE 15G X 1" BE W/CLAMP 820-5002-33

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-19 for JMS WINGEATER SAFETY A-V FISTULA NEEDLE 15G X 1" BE W/CLAMP 820-5002-33 manufactured by Jms Singapore.

Event Text Entries

[121586172] At 1707, 2 hours into a scheduled 3 hour hemodialysis treatment, pt was found unresponsive. Vs at 1655: b/p 119/66; pulse 85. When attempting to administer normal saline, it was noted the venous needle was dislodged, with approx 1. 5 l blood loss. Pressure was held to cannulation site, and normal saline administered via arterial line; 911 was called, cpr was initiated and aed applied which advised no shock. A total of 3 liters of normal saline was administered during the resuscitation. Pt was discharged unresponsive from the clinic and transported to the hosp via ems, where the pt died. Upon inspection of the venous avf needle, it was noted that tape and gauge dressing were still intact on the fistula needle. The machine was sequestered and a functional test was performed. All required parameters passed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7901867
• MDR Report Key: 7901867
• Date Received: 2018-09-19
• Date of Report: 2018-09-19
• Date of Event: 2018-09-06
• Date Facility Aware: 2018-09-06
• Report Date: 2018-09-19
• Date Reported to FDA: 2018-09-19
• Date Reported to Mfgr: 2018-09-19
• Date Added to Maude: 2018-09-24
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: JMS WINGEATER SAFETY A-V FISTULA NEEDLE
• Generic Name: FISTULA NEEDLE
• Product Code: FIE
• Date Received: 2018-09-19
• Model Number: 15G X 1" BE W/CLAMP
• Catalog Number: 820-5002-33
• Lot Number: 180427391
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JMS SINGAPORE
• Manufacturer Address: SINGAPORE 569620 569620

Device Sequence Number: 2

• Brand Name: JMS WINGEATER SAFETY A-V FISTULA NEEDLE
• Generic Name: FISTULA NEEDLE
• Product Code: FIE
• Date Received: 2018-09-19
• Model Number: 15G X 1" BE W/CLAMP
• Catalog Number: 820-5002-33
• Lot Number: 180427391
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: JMS SINGAPORE
• Manufacturer Address: SINGAPORE 569620 SN 569620

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death; 2. Hospitalization	2018-09-19