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 2018-12-07 for WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP 820-5002-33 manufactured by Jms Singapore Pte Ltd.
[129573831]
(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. Furthermore, the user facility had emphasized there were no product problem as upon inspection of the venous avf needle, it was noted that tape were still intact on the fistula needle. Hence, this incident is not related to our manufacturing process. Nonetheless, briefing was conducted to relevant operators and inspectors for their awareness on the reported complaint.
Patient Sequence No: 1, Text Type: N, H10
[129573832]
On (b)(6) 2018, a hemodialysis patient, approximately 2. 5 hours in a scheduled 4 hour hemodialysis treatment when the dialysis machine alarmed. The patient was found in the hemodialysis chair with her eyes closed and venous fistula needle was noted be to be dislodged with the tape intact. Blood was pumping out of the venous needle; a pool of blood was noted under the chair approximately the size of the chair. The blood pump was stopped immediately, and normal saline was administered via the arterial fistula needle. Approximately 400ml normal saline bolus, the patient opened her eyes to verbal instruction. 911 were called. A total of 1. 4 liter of normal saline was administered. Ems with a b/p of 126/961 was discharged on patient. Upon admission to emergency room, her systolic blood pressure was in the 70's and she was bradycardic. 1 liter of fluid and 2 units packed red blood cells (prbc) was infused on the patient. She was admitted to the icu for hemorrhagic shock and discharged from the hospital on (b)(6) 2018, returning for here next scheduled in-center hemodialysis treatment on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2018-00008 |
| MDR Report Key | 8140758 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-12-07 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-10-20 |
| Date Facility Aware | 2018-11-15 |
| Report Date | 2018-11-01 |
| Date Reported to Mfgr | 2018-11-01 |
| Device Manufacturer Date | 2018-06-18 |
| Date Added to Maude | 2018-12-07 |
| 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 15GX1" BE 30CM W/CLAMP |
| Generic Name | JMS WINGEATER A.V.FISTULA NEEDLE SET |
| Product Code | FIE |
| Date Received | 2018-12-07 |
| Model Number | 820-5002-33 |
| Lot Number | 180618371 |
| 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 | 2018-12-07 |