MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2017-09-15 for WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP 820-5002-33 manufactured by Jms Singapore Pte Ltd.
[86338540]
Although we have not established that the device caused or contributed to the event, we are reporting it out of caution to be in compliance with 21cfr part 803 due to fatal incident. Based on the results of reserve sample evaluation and device history record review, there was no abnormality found on the reported lot number. The products met the qa specifications prior releasing it to the market. Jms had reviewed the associated product quality records and although the jms wingeater was associated in this incident, no cause or contributing factor could be clearly related to the jms avf wingeater device in use. Although there is no doubt that the needle set moved (dislodged) from intended location, there was no clear product problem. The accurate event description suggests that involuntary patient movement or combination of other factors may possibly be the most likely contributed to needle dislodgement that eventually caused unknown quantity of blood loss. However, again, we are hindered from obtaining more factual information about the event due to unknown initial reporter. Though jms(b)(4) had tried several attempts to gather information related the event from the hospitals using the affected lot number. However, none could confirm the event occurred on site. Hence, a request was made by jms(b)(4) to fda on 30 august 2017 to inquire for the original report under #fda (b)(4). Supplementary report will be issued when sufficient information from fda is available.
Patient Sequence No: 1, Text Type: N, H10
[86338541]
Dated 15 august 2017, jms regulatory affairs went through the maude database and found out there was a death case with mdr report key (b)(4) not recorded in jms database. Hence, jms continued to search for initial reporter information while regulatory affairs section reviewed product related data. It is possible that initial reporter thought that they had reported to manufacturer but by mistake possibly informed another manufacturer or distributer. From 15 august 2017 to 7 september 2017, several attempts were made by jms(b)(4) to gather more information from the hospitals which had received the affected lot number but none could confirm the event occurred on site. Hence, a request was made by jms(b)(4) to fda on 30 august 2017 to inquire for the original report. Request confirmation email was sent from fda and still pending for a response from fda. (#fda (b)(4)). Further research on maude database for mdr report key (b)(4) was conducted and understood the incident as needle dislodgement. There was difficulties encountered during cannulation and the hemodialysis machine was alarmed at least twice during approximately the first 10 - 15 minutes of hemodialysis. However, without an accurate initial reporter's narrative, we do not know exactly what had happened in this adverse event. We did not know whether there was any typo error on pre-hd blood pressure as pre-hd blood pressure diastolic of 8 would raise concern of contributing health factors. Below stated are the available information we currently have. Patient was admitted to hospital for inpatient hemodialysis on (b)(6) 2017. The patient has a right thigh av graft and was also nonverbal. (patient's bp 113/8 and pulse 85). Patient was cannulated with two 15g needles and some difficulties were encountered during cannulation. Hemodialysis was initiated at approximately 1150 hrs. The hemodialysis machine was alarmed at least twice during approximately the first 10~15 minutes of hemodialysis. It was discovered that one of the needle appeared to be dislodged and blood was surrounding at the patient's right leg. However, the quantity of blood loss was undetermined. Pulse's check was conducted on patient and no pulse was noted. The patient did not resuscitate. Hence, no cardiopulmonary resuscitation (cpr) was initiated. Hospital rapid response team arrived but patient had expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2017-00005 |
| MDR Report Key | 6867891 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2017-09-15 |
| Date of Report | 2017-09-15 |
| Date Facility Aware | 2017-08-15 |
| Date Mfgr Received | 2017-08-15 |
| Device Manufacturer Date | 2016-10-28 |
| Date Added to Maude | 2017-09-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 | BATAM KEPULAUAN RIAU, INDONESIA 24933 |
| Manufacturer Country | ID |
| Manufacturer Postal Code | 24933 |
| 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 | 2017-09-15 |
| Model Number | 820-5002-33 |
| Lot Number | 161028372 |
| Device Availability | * |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-09-15 |