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 2018-10-03 for WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP 820-5002-33 manufactured by Jms Singapore Pte Ltd.
[123793408]
(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 preserved samples evaluation and dhr analysis, there was no abnormality found on complaint lot. From the information gathered from (b)(4), user facility said that their suspicion might be due to patient movement. Furthermore, the user facility had emphasized there were no product problem as upon inspection of the venous avf needle, it was noted that tape and gauze dressing were still intact on the fistula needle. Hence, this incident is not related to our manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
[123793509]
On (b)(6) 2018, a hemodialysis patient was going through a 3 hour hemodialysis treatment that involved venous needle dislodgement, hospitalization and death. Two (2) hours into the scheduled treatment, patient was found to be unresponsive. Pressure was held to cannulation site, and normal saline administered via arterial line. Approximately 1. 5l of blood loss. 911 were called, cpr was initiated and aed applied which advised no shock. A total of 3 liters of normal saline was administered during resuscitation. The patient was then transported to the hospital via ems, where the patient died. Upon inspection of the venous needle, it was noted that tape and gauze dressing were still intact on the fistula needle. The machine was sequestered and functional test was performed. All required parameters passed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2018-00006 |
| MDR Report Key | 7968150 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-10-03 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-08-08 |
| Date Facility Aware | 2018-09-28 |
| Report Date | 2018-09-19 |
| Date Reported to FDA | 2018-09-19 |
| Date Reported to Mfgr | 2018-09-19 |
| Date Mfgr Received | 2018-09-28 |
| Device Manufacturer Date | 2018-04-27 |
| Date Added to Maude | 2018-10-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2018-10-03 |
| Model Number | 820-5002-33 |
| Lot Number | 180427391 |
| 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. Death; 2. Hospitalization | 2018-10-03 |