MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-11-14 for WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP 820-5002-33 manufactured by Jms Singapore Pte Ltd.
[59893586]
(b)(4). 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 21 cfr part 803. We cannot rule out causality. Based on (b)(4) information collected from the health care worker, it is possible that the device did not directly contribute to the adverse event. Also, the recurrence of a similar incident within a home-healthcare based setting could possibly have severe consequences that could result in permanent injury or death. (b)(4) investigation with the health care worker revealed that for this specific adverse event, the patient was not self-administering enough anti-coagulant medication, namely heparin, for his blood to physically move through all the inner components of the hemodialysis blood tubing circuitry (including blood lines and in this event, the dialyzer cassette). The patient also refuse to take otc (over-the-counter) aspirin as directed by his physician. Also, the patient admitted to the healthcare staff that his greatest suspicion was his digestion because at the time he preferred to eat during his dialysis treatment and that activity had negative consequences to his treatment. He has since modified his eating so that it does not affect his treatment, however, he continues to struggle with maintaining proper heparin dosage, and is scheduled for on-going in-depth physician monitoring. Moreover, the luer connectors of jms wingeater product and the dialyzer device are fully compatible. The patient does not suffer from any previous personal injury (arthritis, rheumatism, broken wrist, hand or fingers, etc) that would compromise the ability to connect the components together. The patient was able to fasten a secure connection between both devices and no poor connection was suspected in this event. Based on jmss investigation, review of reserve sample and device history record showed that there was no abnormality found on the reported product lot. Our manufacturing process was within control and there was no abnormality found on the reported product lot and the products met all the qa outgoing inspection criteria prior to releasing it into the market. There was no reported or detected malfunction on the needle itself. Thus, no corrective action will be applicable as reported incident is not related to any malfunction of jmss product. From year 2011 to july 2015 about (b)(4) sets of the reported product family were manufactured and distributed worldwide with no such defect occurred in the market. Jms will continue to maintain good quality of our products and ensure that only good quality products are delivered to customers.
Patient Sequence No: 1, Text Type: N, H10
[59893587]
Initial report: clotting incidents occurred while using needle. Additional information: patient reported several episodes of past 3 months of venous needle clotting resulting in early termination of therapy and loss of blood. Patient describes seeing clot at junction between venous line and venous needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2015-00002 |
| MDR Report Key | 6101198 |
| Report Source | USER FACILITY |
| Date Received | 2016-11-14 |
| Date of Report | 2015-07-20 |
| Date of Event | 2015-07-14 |
| Date Facility Aware | 2015-07-16 |
| Report Date | 2015-07-18 |
| Date Reported to Mfgr | 2015-07-18 |
| Date Mfgr Received | 2015-07-18 |
| Device Manufacturer Date | 2014-07-03 |
| Date Added to Maude | 2016-11-14 |
| 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 | MS. CHIN YIN CHIA |
| Manufacturer Street | 440, ANG MO KIO INDUSTRIAL PARK 1 |
| Manufacturer City | 569620 |
| Manufacturer Country | SN |
| Manufacturer Postal | 569620 |
| Manufacturer Phone | 71176 |
| Manufacturer G1 | JMS SINGAPORE PTE LTD |
| Manufacturer Street | 440 ANG MO KIO INDUSTRIAL PARK 1 |
| Manufacturer City | SINGAPORE, 569620 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 569620 |
| 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 | A.V.FISTULA NEEDLE SET |
| Product Code | FIE |
| Date Received | 2016-11-14 |
| Model Number | 820-5002-33 |
| Lot Number | 140703341 |
| Device Expiration Date | 2019-07-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JMS SINGAPORE PTE LTD |
| Manufacturer Address | 440 ANG MO KIO INDUSTRIAL PARK 1 SINGAPORE, 569620 SN 569620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-14 |