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 2019-01-23 for WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP 820-5002-33 manufactured by Jms Singapore Pte Ltd.
[133839532]
(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 for reported lot 180823351. 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. As per information provided by facility and jmsna, there were no product problems before, during or after use with venous needle. Hence, this incident is not related to our manufacturing process. Nonetheless, briefing was conducted on (b)(4) 2019 on all related operators and inspectors for their awareness on the reported defect. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[133839533]
On (b)(6) 2018, a hemodialysis patient, arrived to treatment alert and orientated. Pre-dialysis vital signs obtained: b/p: 152/77; pulse 73; resp 20; temp: 97. 6. Treatment was initiated at 13:21, and vs checked every 20 minutes. At 14:01, b/p was 128/68; pulse 75. Approximately 8 minutes later, the machine alarmed. The patient was found unresponsive with the tip of the venous needle dislodged. Tape was still intact on the patient's skin. Large amounts of blood were noted on the floor. Ebl 300-400 ml. The venous line was clamped and pressure applied to the venous cannulation site. Blood was returned via the arterial needle, and normal saline was administered via the arterial needle; approximately 800 ml normal saline was administered. Oxygen was applied via mask at 3 lpm; aed pads placed on chest; cpr initiated. 911 was called. The patient started spontaneously breathing at 14:13. Vs upon discharge from facility: b/p 156/99; pulse 102; resp 23; temp 97. 8. The patient was transported to the hospital via ems and admitted. Patient was transfused with 3 units of packed red blood cells (prbcs) during hospitalization and was discharged (b)(6) 2019, returning to the facility for hemodialysis on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2019-00001 |
| MDR Report Key | 8269836 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-01-23 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-12-27 |
| Date Facility Aware | 2019-01-16 |
| Report Date | 2019-01-10 |
| Date Reported to Mfgr | 2019-01-10 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2018-08-23 |
| Date Added to Maude | 2019-01-23 |
| 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 |
| 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 | 2019-01-23 |
| Model Number | 820-5002-33 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 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; 2. Life Threatening | 2019-01-23 |