MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-04-04 for WINGEATER A.V.FISTULA 17G X 11/4" BE 30CM W/CLAMP 820-7005-33 manufactured by Jms Singapore Pte Ltd.
[71678356]
(b)(4). Although we have established that the device did not cause or contribute to the event, we are reporting it out of caution to be in compliance with 21cfr part 803 due to the fatal incident. Based on the information provided by donor center, there was no record of any of the products/ lots used during donation having had any defects or noted issues. Medical department from donor center had determined that the fatality was unrelated to the donation. Jms wingeater a. V. Fistula needle was only associated with the event. 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. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[71678357]
Donor experienced a heart attack which proved fatal following a donation at the facility, (b)(6) on (b)(6) 2017. The center did not have any record for the products/ lots used during donation having any defects or noted issues. As part of their investigation, the center was requesting documentation from the soft goods manufacturer if there is any issue with the lots of items used during the donor's donation. The actual jms needle had been disposed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2017-00001 |
| MDR Report Key | 6459236 |
| Report Source | USER FACILITY |
| Date Received | 2017-04-04 |
| Date of Report | 2017-04-05 |
| Date of Event | 2017-03-06 |
| Date Facility Aware | 2017-03-15 |
| Report Date | 2017-03-15 |
| Date Reported to Mfgr | 2017-03-15 |
| Date Mfgr Received | 2017-03-15 |
| Device Manufacturer Date | 2016-11-03 |
| Date Added to Maude | 2017-04-04 |
| 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 | PT.JMS BATAM |
| Manufacturer Street | LOT 211 JALAN BERINGIN MUKA KUNING |
| Manufacturer City | BATAMINDO INDUSTRIAL PARK, BATAM 29433 |
| Manufacturer Country | ID |
| Manufacturer Postal Code | 29433 |
| 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 | FISTULA NEEDLE |
| Product Code | FIE |
| Date Received | 2017-04-04 |
| Model Number | 820-7005-33 |
| Lot Number | 161103381 |
| Operator | PHLEBOTOMIST |
| Device Availability | N |
| Device Age | 4 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 | 2017-04-04 |