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.
[129572100]
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. The user facility had emphasized there were no product problem as upon inspection of the venous avf 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 defect. It was noted that 1 piece of tape across wing was no longer on patient's skin and needle but 2 other pieces were intact on skin and on needle.
Patient Sequence No: 1, Text Type: N, H10
[129572101]
On (b)(6) 2018, a hemodialysis patient, approximately 45 minutes into a scheduled 4 hour hemodialysis treatment when the dialysis machine alarmed arterial pressure. The patient was found in the hemodialysis chair with venous fistula needle dislodged with the tape intact on wings of the venous fistula needle. A pool of blood was noted below the chair, which continued to the wall behind the chair. Chair was in semi-reclined position. Ebl 300 ml. Patient was unresponsive with erratic respiratory rate. Blood pressure was 112/60, pulse 60. 2 liters of normal saline was administered through arterial needle. Patient was placed in trendelenburg position and oxygen of 10 l was applied via nasal cannula. Patient was drowsy but responding to verbal stimuli. Ems was called. One unit of packed red blood cells (prbc) was administered in the er and patient was then discharged home. The patient returned to the facility for his next scheduled hemodialysis appointment treatment on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2018-00009 |
| MDR Report Key | 8140757 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-12-07 |
| Date of Report | 2018-11-27 |
| Date of Event | 2018-10-27 |
| Date Facility Aware | 2018-11-23 |
| Report Date | 2018-11-23 |
| Date Reported to Mfgr | 2018-11-23 |
| Date Mfgr Received | 2018-11-23 |
| Device Manufacturer Date | 2018-05-31 |
| 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 | 180531361 |
| 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 | 440 ANG MO KIO INDUSTRIAL PK 1 SINGAPORE, 569620 SN 569620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-12-07 |