MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-12-19 for WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP 820-5002-33 manufactured by Jms Singapore Pte Ltd.
[130988935]
(b)(4). 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 based on the lot 180519391 and 180622391. 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. The user facility pct did not report any problems with luers when pct tightened the connection administering normal saline and continue to return the blood. The clinical manager reported that the leak was due to a loose connection and suspects that the luer connector was not tightened properly during setup. Nonetheless, briefing was conducted on (b)(4) 2018 to all related operators and inspectors for their awareness on the reported adverse event.
Patient Sequence No: 1, Text Type: N, H10
[130988936]
A hemodialysis patient scheduled 3. 75 hour hemodialysis treatment was initiated at 11:40am. B/p 122/73, pulse 92. At 12:26, b/p was 103/43, pulse 89; 300 ml normal saline was administered. Normal saline was administered over the next 2 hours for hypotension, totaling 1700ml. When discontinuing treatment at 14:32, the pct picked up the venous bloodline and noted it was not securely tightened to the fistula needle and was leaking blood. The pct tightened the connection to administered normal saline and continue to return the blood. Blood was noted on the floor; no blood was noted on the front of the patient, chair, or chairside table. It appeared blood was dripping on the outside of his arm to the floor. 600ml normal saline was administered. Patient did not lose consciousness at any time. Ems was called and the patient was transported to the hospital and admitted. Upon discharge the dialysis facility, the patient was awake and alert, and b/p was 114/48; pulse 89; resp 17; temp 97. 5. Patient received 3 units of packed red blood cells (prbcs) during the hospitalization. He was discharged from the hospital (b)(6) 2018, returning for hemodialysis on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2018-00010 |
| MDR Report Key | 8182752 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-10-31 |
| Date Facility Aware | 2018-12-04 |
| Report Date | 2018-11-14 |
| Date Reported to Mfgr | 2018-11-14 |
| Date Mfgr Received | 2018-12-04 |
| Device Manufacturer Date | 2018-06-22 |
| Date Added to Maude | 2018-12-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHIA CHIN YIN |
| Manufacturer Street | 440 ANG MO KIO INDUSTRIAL PK 1 |
| Manufacturer City | SINGAPORE, 569620 |
| Manufacturer Country | SN |
| Manufacturer Postal | 569620 |
| Manufacturer G1 | PT.JMS BATAM |
| Manufacturer Street | LOT 211 JALAN BERINGIN BATMINDO IND.PARK MUKA KUNING |
| Manufacturer City | INDONESIA |
| Manufacturer Country | ID |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP |
| Generic Name | JMS WINGEATER A.V.FISTULA NEEDLE SET |
| Product Code | FIE |
| Date Received | 2018-12-19 |
| Model Number | 820-5002-33 |
| Lot Number | 180622391 |
| Device Expiration Date | 2018-06-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JMS SINGAPORE PTE LTD |
| Manufacturer Address | 440 ANG MO KIO INDUSTRIAL PK 1 SINGAPORE, 569620 SN 569620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-12-19 |