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 2019-01-14 for SYSLOC MINI AVF 15GX1" BE 30CM W/CLAMP 864-1500-33 manufactured by Jms Singapore Pte Ltd.
[132922615]
(b)(4). 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 based on the reported lot 180608332. 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 the information provided by facility and jmsna, no defect or malfunction was observed of the jms sysloc mini avf. Hence, this incident is not related to our manufacturing process. Nonetheless, briefing was conducted on 26 dec 2018 to all related operators and inspectors for their awareness on the reported defect. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[132922616]
On (b)(6) 2018, a hemodialysis patient, approximately 45 minutes into a scheduled 3. 5 hour hemodialysis treatment, the venous fistula needle was found to be leaking blood around the cannulation site. Staff reported venous needle was partially dislodged. The tape was intact on the wings of the fistula needle and secured to the patient. The patient was unresponsive to verbal commands. Vs: b/p: 79/39, pulse: 104. Blood was partially returned via the venous fistula needle. The venous cannulation site infiltrated and the remaining blood was returned via the arterial fistula needle. Approximately 800 mls normal saline was administered. Ems was called. Upon discharge from the facility via ems, b/p was 101/69, pulse 100, resp 18. The patient was awake and alert upon discharge. He was admitted to the hospital. 2 units of packed red blood cells (prbcs) were infused. The patient returned to the facility for hemodialysis on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2018-00011 |
| MDR Report Key | 8243170 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-01-14 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-11-23 |
| Date Facility Aware | 2018-12-24 |
| Report Date | 2018-12-24 |
| Date Reported to Mfgr | 2018-12-24 |
| Date Mfgr Received | 2018-12-24 |
| Device Manufacturer Date | 2018-06-08 |
| Date Added to Maude | 2019-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | 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 | SYSLOC MINI AVF 15GX1" BE 30CM W/CLAMP |
| Generic Name | JMS SYSLOC MINI A.V. FISTULA NEEDLE SET |
| Product Code | FIE |
| Date Received | 2019-01-14 |
| Model Number | 864-1500-33 |
| Lot Number | 180608332 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JMS SINGAPORE PTE LTD |
| Manufacturer Address | JMS SINGAPORE PTE LTD SINGAPORE, 569620 SN 569620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-01-14 |