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 2019-02-08 for WINGEATER A.V. FISTULA 15G X1" 30CM W/CLAMP 820-5002-33 manufactured by Jms Singapore Pte Ltd.
[135507557]
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 reserved samples evaluation and dhr analysis, there was no abnormality found on complaint lot. Investigation was carried out for reported lot 180804361. Based on the results of dhr analysis and reserve samples evaluation, there was no abnormality found on the reported product lot. We would like to emphasize that our manufacturing process was within control and all our products met the jms qa outgoing inspection criteria prior to market release. As per information provided by facility and jmsna, there were no product problems found on venous needle at any time. Hence, this incident is not related to our manufacturing process. Nonetheless, briefing was conducted on 21 jan 2019 on all related operators and inspectors for their awareness on the reported defect.
Patient Sequence No: 1, Text Type: N, H10
[135507558]
On (b)(6) 2018, a hemodialysis patient, (age: (b)(6), gender: female; estimated dry weight: (b)(6)), arrived to treatment alert and oriented. Pre-dialysis vital signs obtained: b/p: 187/62; pulse 72; resp 18; temp: 98. 0. At 19:59, the patient was observed with access covered and no bleeding from site. At 20:01, approximately 2. 5 hours into scheduled 4 hour hemodialysis treatment during the q 30 minute vital signs check, the patient was noted to be slow to respond. Vs obtained: b/p 47/26; pulse 64. Patient's venous needle was dislodged with tape intact on the wings of the needle. Large amount of blood was noted on both the chair and the floor. Ebl 500ml. The venous line was clamped and pressure applied to the venous cannulation site. Normal saline was administered via the arterial needle. 911 was called. After infusion of approximately 1000ml normal saline, b/p: 126/53; pulse 64; patient was alert and oriented. Upon discharge from the facility via ems, the patient was alert and oriented with b/p 110/50; pulse 67; resp 18. The patient was transported to the hospital and admitted. The patient returned to the facility for hemodialysis on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2019-00002 |
| MDR Report Key | 8319395 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-02-08 |
| Date of Report | 2019-01-03 |
| Date of Event | 2018-12-19 |
| Date Facility Aware | 2019-01-21 |
| Report Date | 2019-01-04 |
| Date Reported to Mfgr | 2019-01-04 |
| Date Mfgr Received | 2019-01-21 |
| Device Manufacturer Date | 2018-08-04 |
| Date Added to Maude | 2019-02-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 15G X1" 30CM W/CLAMP |
| Generic Name | JMS WINGEATER A.V. FISTULA NEEDLE SET |
| Product Code | FIE |
| Date Received | 2019-02-08 |
| Model Number | 820-5002-33 |
| Lot Number | 180804361 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 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. Hospitalization | 2019-02-08 |