MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-18 for A.V FISTULA NEEDLE SET 820-5002-33 manufactured by Jms Singapore Pte Ltd..
[131505700]
Hemodialysis pt scheduled for regular dialysis treatment. Pre bp 132/83, pulse 76, resp 16, temp 98. 6. Hemodialysis initiated via left upper avg utilizing 2 # 15 gauge wingeater needles. Treatment initiated at approx 1309 for a 4 hr treatment. At approx 1435 bp 150/71, pulse 80. At approx 1510, pt appeared to be in distress and placed in trendelenburg position, blood was noted under pt's chair. No reported audible machine alarm. Pt unresponsive, normal saline was administered via venous line, normal saline was noted seeping through venous line. Normal saline was then administered via arterial line, normal saline was noted seeping through arterial line. Tape and 2x2 gauze which was placed over both needle sites was removed. The arterial and venous needle were dislodged out of the pt's left upper avg, with the tape remaining attached to the pt's arm and to both needles; 911 called, oxygen provided, cpr was initiated. Ems arrived and took over care of pt, pt was transported to hospital and expired in the er.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8199119 |
| MDR Report Key | 8199119 |
| Date Received | 2018-12-18 |
| Date of Report | 2018-01-11 |
| Date of Event | 2017-12-29 |
| Date Facility Aware | 2017-12-29 |
| Report Date | 2018-01-11 |
| Date Reported to FDA | 2018-01-12 |
| Date Reported to Mfgr | 2018-01-12 |
| Date Added to Maude | 2018-12-27 |
| 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 | 3 |
| 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 | 3 |
| Brand Name | A.V FISTULA NEEDLE SET |
| Generic Name | WINGEATER 15G X 1" |
| Product Code | FIE |
| Date Received | 2018-12-18 |
| Model Number | 820-5002-33 |
| Lot Number | 170825371 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JMS SINGAPORE PTE LTD. |
| Manufacturer Address | SINGAPORE SN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 3 | 1. Death | 2018-12-18 |