MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-12-11 for WINGEATER A.V.FISTULA 17G X 11/4" BE 30CM W/CLAMP 820-7005-33 manufactured by Jms Singapore Pte Ltd.
[62074504]
(b)(4). 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, because of the fatality. As per the information provided by donor center, there was no documentation indicated that there was any abnormality observed on jms wingeater set prior to the donation process and the facility ((b)(6)) did not think that jms wingeater needle set might have contributed to the fatal incident. Based on evaluation results of the investigation carried out, cause of reported event was unlikely to be related to jms(b)(4) as the manufacturing process was within control, the product was found to be with specification and it met all the qa outgoing inspection criteria prior to releasing it into market. In regard to this specific product lot, we have had no reported defect at all to date and lot size (quantity) is (b)(4). From 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. There was no malfunction on the needle itself. Lastly, jms will continue to maintain good quality of our products and ensure that only good quality products are delivered to customers. We will continue to work with our customers to improve our products quality.
Patient Sequence No: 1, Text Type: N, H10
[62074565]
Initial report: the plasma collection facility, (b)(6) noted in section ei is requesting documentation from the soft goods manufacturer if there is any issue with the lots of items used during the donor's donation. Jms needle involved: 820-7005-33, lot #160408331. Information from (b)(6) on (b)(6) 2016: on (b)(6) 2016, 3rd party information from a donor notified the center on the fatal incident. On (b)(6) 2016, the donor's sister came to center in person to provide contact information and let the center know that he had passed. The cause of the fatal incident was due to massive heart attack. The donor's last donation prior to donation before death was (b)(6) 2016. Throughout the donation, donor has had multiple out of range results for blood pressure, pulse and temperature. It was noted on donor record file (drf) that donor was taking amlodipine for blood pressure and lisinoprilhetz. It was recorded in drf that "donor stated he takes medication daily as prescribed. " it was also recorded that he took medication within 72 hours of donation according to drf on (b)(6) 2016. The donation was completed with collected plasma of 825ml. No saline was administered during the procedure. The donor had made 232 donations and on average, he would donate bi-weekly. The center had been notified by the chief medical officer, dr, (b)(6) that the fda will be coming to the center.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2016-00013 |
| MDR Report Key | 6165484 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-12-11 |
| Date of Report | 2016-12-12 |
| Date of Event | 2016-11-04 |
| Date Facility Aware | 2016-11-15 |
| Report Date | 2016-11-16 |
| Date Reported to Mfgr | 2016-11-16 |
| Date Mfgr Received | 2016-11-16 |
| Device Manufacturer Date | 2016-04-08 |
| Date Added to Maude | 2016-12-11 |
| 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 |
| Reporter Occupation | PHLEBOTOMIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHIN YIN CHIA |
| Manufacturer Street | 440, ANG MO KIO INDUSTRIAL PARK 1 |
| Manufacturer City | 569620 |
| Manufacturer Country | SN |
| Manufacturer Postal | 569620 |
| Manufacturer Phone | 71176 |
| Manufacturer G1 | JMS SINGAPORE PTE LTD |
| Manufacturer Street | 440 ANG MO KIO INDUSTRIAL PARK 1 |
| Manufacturer City | SINGAPORE, 569620 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 569620 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WINGEATER A.V.FISTULA 17G X 11/4" BE 30CM W/CLAMP |
| Generic Name | NEEDLE FISTULA |
| Product Code | FIE |
| Date Received | 2016-12-11 |
| Model Number | 820-7005-33 |
| Lot Number | 160408331 |
| Operator | PHLEBOTOMIST |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JMS SINGAPORE PTE LTD |
| Manufacturer Address | 440 ANG MO KIO INDUSTRIAL PARK 1 SINGAPORE, 569620 SN 569620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-12-11 |