MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-11-14 for WINGEATER A.V.FISTULA 17GX11/4" 30CM W/CLAMP 820-7005-33 manufactured by Jms Singapore Pte Ltd.
[59835471]
(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. We cannot rule out causality. Based on the information collected by jmsna, there was nothing abnormal noticed on the donor during and after the blood donation process. The donor was found to be stable after the donation. On the same day, he suffered from a heart attack and died 4 days later. From reserve sample evaluation and device history record review, there was no abnormality found on the reported product lot. The products met the qa specifications prior releasing it to the market. There was no reported or detected malfunction on the needle itself. Thus, no corrective action will be applicable as reported incident is not related to any malfunction of jms product. Jms will continue to maintain good quality of our products and ensure that only good quality products are delivered to customers.
Patient Sequence No: 1, Text Type: N, H10
[59835472]
Donor (b)(6) was a qualified male who completed a successful donation on (b)(6) 2015 and returned home. On (b)(6) 2015, his wife reported that the donor complained of chest pain and sweating and suffered a heart attack at his home. The donor was transported to the hospital, was maintained on life support, and died on (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2015-00004 |
| MDR Report Key | 6101299 |
| Report Source | USER FACILITY |
| Date Received | 2016-11-14 |
| Date of Report | 2015-12-10 |
| Date of Event | 2015-11-23 |
| Date Facility Aware | 2015-12-10 |
| Report Date | 2015-12-10 |
| Date Reported to Mfgr | 2015-12-10 |
| Date Mfgr Received | 2015-12-10 |
| Device Manufacturer Date | 2015-07-08 |
| Date Added to Maude | 2016-11-14 |
| 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 | 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 17GX11/4" 30CM W/CLAMP |
| Generic Name | A.V.FISTULA NEEDLE SET |
| Product Code | FIE |
| Date Received | 2016-11-14 |
| Model Number | 820-7005-33 |
| Lot Number | 150708331 |
| Operator | PHLEBOTOMIST |
| Device Availability | N |
| Device Age | 6 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; 2. Hospitalization; 3. Life Threatening; 4. Required No Informationntervention | 2016-11-14 |