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.
[59836795]
(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 21cfr part 803. Although we could not establish causal effect (either use error or product defect), we did due diligence and investigated 10 lots before and 10 lots after the current-lot-in use, in an effort to further substantiate that our components are in compliance with applied standards. Due to unavailability of actual sample involved in the event, we are unable to verify the actual cause of the reported claim. Based on all the testing conducted on the product lot that the clinic was currently using and also on the neighboring lots (10 lots before and 10 lots after the lot in-current-use by the clinic), we would like to assure that our avf joints (luer connectors) are strictly in compliance with iso 594/1 & iso 594/2. From reserve sample evaluation on the lot number that the clinic was currently using as well as the neighboring lots (10 lots before and 10 lots after the current lot in use by the clinic) and device history record review, there was no abnormality found and the product lots met the qa outgoing inspection criteria prior releasing it to the market. There was no abnormality identified on the needle itself. As per the information provided by the facility staff, the disconnection occurred after 3hr into dialysis treatment. The patient care technician in-charge did not find any defects or abnormalities with the avf needle upon visual inspection prior usage. No abnormality was observed during the connection fitting of avf joint (female luer connector) to the bts connection (male luer connector). They mentioned that the avf set disconnected from the bts venous line at the luer connector. However, according to the facility, they do not know how this actual incident occurred and not sure whether the machine alarmed when the disconnection happened. There was no actual defect identified / reported on the needle within the adverse event. The facility did not take note of the lot number of the device that was involved in the event and moreover the sample that was involved in the event was discarded by the clinic. Due to unavailability of lot number and defective sample, we are unable to identify the actual root cause of this claim. However, investigation was carried out based on 10 lots before and 10 lot after of the current lot in-use (141128331). Moreover, we did an in-depth investigation by checking our related quality assurance and production processes and observed that all the processes were within control. Thus, no corrective action will be applicable as reported incident is not related to any malfunction of jms product. (b)(4). Jms(b)(4) 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
[59836796]
On (b)(6) 2015 at approximately 3 hours into a scheduled 3? Hour treatment, it was noted that patient had blood under her chair. Patient immediately assessed. Patient was unresponsive, diaphoretic, and agonally breathing. Blood pressure was 87/57 and heart rate was 42. Estimated blood loss was approximately 600cc. It was determined that the venous line had disconnected from the venous needle connection. There was an additional estimated blood loss of approximately 300 cc of blood in the dialyzer and lines that was not able to be returned to the patient. Patient was given 2000 cc of normal saline at which time she became responsive. Blood pressure was then 84/46, heart rate 54. Patient was transported via ambulance to the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2015-00003 |
| MDR Report Key | 6101235 |
| Report Source | USER FACILITY |
| Date Received | 2016-11-14 |
| Date of Report | 2015-08-21 |
| Date of Event | 2015-08-08 |
| Date Facility Aware | 2015-08-20 |
| Report Date | 2015-08-21 |
| Date Reported to Mfgr | 2015-08-21 |
| Date Mfgr Received | 2015-08-21 |
| Device Manufacturer Date | 2014-11-28 |
| 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 | 141128331 |
| Device Expiration Date | 2019-11-27 |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 10 MO |
| 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. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2016-11-14 |