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 2017-09-29 for WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP 820-5002-33 manufactured by Jms Singapore Pte Ltd.
[87721604]
Although we have not established that the device caused or contributed to the event, we are reporting it out of caution to be in compliance with 21cfr part 803 due to transfer of the patient to emergency room for precautionary check on his blood hemoglobin. Jms did due diligence and conducted an investigation as a precaution if the device contributed to the adverse event. Based on the results of reserve sample evaluation and device history record review, there was no abnormality found on the lot number in use at facility the products met the qa specifications prior releasing it to the market. Jms had reviewed the associated product quality records and although the jms wingeater was associated in this incident, no cause or contributing factor could be clearly related to the jms avf wingeater device in use. The actual sample involved in the event is unavailable for evaluation. We have determined the actual cause of reported incident to be the poor connection of bloodline to jms avf wingeater. There was no dislodgement of jms avf wingeater. When the staff changed a new bloodline and reconnected to the jms avf wingeater using the same machine, the treatment continued and completed without incident. From the product pamphlet, instruction for use (ifu) that accompanies the device, end-user is cautioned to firmly join the connectors to each other. All connections must be checked carefully prior to and during the first minutes of operation. During treatment, connections must be visually inspected periodically to detect leaks and avoid blood loss.
Patient Sequence No: 1, Text Type: N, H10
[87721605]
During hemodialysis (hd) treatment, a patient (b)(6) reportedly lost approximately 800 to 1000 milliliters (ml) of blood after the venous needle became disconnected from the bloodlines. The connection was between the luer connector of jms avf needle and bloodline. The connectors were attached to each other and screwed into place. There was no taping at luer connector to bloodlines and no lubricant or disinfectant was used at the connecting portion. The staff did not observed any abnormalities during/ after connection fitting or during periodic check. The disconnection incident occurred around 2 hours and 45mins into the hemodialysis treatment. The total duration for patient took 4 hours to complete his hemodialysis treatment. The staff saw the blood leakage and moved to action. However, the staff was unsure whether the disconnection was due to the movement of patient. There was no jms avf wingeater needle dislodgement from patient access as reconfirmed by user-facility staff. The blood leakage came from the connection to the bloodline. When the bloodline was changed and reconnected to the jms avf wingeater needle, the patient was able to complete his treatment without further incident. The machine did not alarmed and the leak occurred on the return side. No patient adverse reaction was reported. The patient went to the emergency room (er) for a precautionary check of the patient's hemoglobin. The results were within normal range and the patient was sent home and was not admitted to the hospital. There was no indication of a needle and/ or bloodline malfunction or defect. No samples are available to be returned. Training is conducted regularly to healthcare personnel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2017-00006 |
| MDR Report Key | 6903244 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-09-29 |
| Date of Report | 2017-09-26 |
| Date of Event | 2017-08-04 |
| Date Facility Aware | 2017-09-05 |
| Report Date | 2017-09-05 |
| Date Reported to FDA | 2017-09-05 |
| Date Reported to Mfgr | 2017-09-06 |
| Date Mfgr Received | 2017-09-06 |
| Date Added to Maude | 2017-09-29 |
| 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 | BATAM KEPULAUAN RIAU, INDONESIA 24933 |
| Manufacturer Country | ID |
| Manufacturer Postal Code | 24933 |
| 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 | 2017-09-29 |
| Model Number | 820-5002-33 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 440 ANG MO KIO INDUSTRIAL PK 1 SINGAPORE 569620 SN 569620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-29 |