MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2017-08-17 for WINGEATER A.V.FISTULA 15GX1" BE 30CM W/CLAMP 820-5002-33 manufactured by Jms Singapore Pte Ltd.
[82871914]
Although we have established that the device did not cause or contribute to the event, we are reporting it out of caution to be in compliance with 21 cfr part 803 due to the medical intervention of 600 ml saline bonus administered on patient and the transfer of patient to the emergency room at hospital. Jmss did due diligence and conducted an investigation as a precaution if the device contributed to the adverse event. Based on our reserve sample evaluation and device history record of the reported product lot (161227381), there was no abnormality found. The products met the qa specifications prior releasing it to the market. No abnormality was observed on the dimension of conical fitting of the reserved samples as they met the requirement indicated in iso 594/1 - 5. 1 gauging test. The actual sample involved in the event is unavailable for evaluation, we have determined the actual cause of reported incident to be end-user error. There was no visible or obvious defect observed on jmss avf wingeater prior to use and the employee did not feel anything unusual from the connection at the initial stage of treatment. Cross-threading was the cause of leakage because when the nurse disconnected and reconnected the lines, it stopped the blood leakage completely at that time. 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
[82871915]
A healthcare professional at a user facility reported that a blood leak event occurred at the connection point between the fmc combi blood tubing set and the wingeater a. V. Fistula (15g 1" fistula needle). They were not sure exactly when the blood leakage started. Cross-threading was discovered during a safety check when the patient lifted her arm. However, when the nurse disconnected and reconnected the lines, blood leakage stopped completely at that time. Cross-thread connection between luer connector and fmc combi bts was observed at 45 minutes into treatment. It resulted in an estimated blood loss (ebl) > 200 milliliter (ml). The blood pump was stopped. The nurse untwisted and reconnected the lines to stop the leakage. The patient was transported to the emergency room (er) but not admitted in hospital. On the 29 june 2017, it was confirmed that the patient experienced blood loss at 42 minutes into a 3 hours 15 minutes treatment. The estimated blood loss (ebl) was approximately 500 ml. The patient experienced chest pains and was lethargic. A 600 ml saline bolus was given and the chest pains subsided. No transfusion was needed. The treatment was discontinued and the patient was transferred to the hospital for the reported chest pain. The patient was evaluated to be stable from blood loss and discharged. The patient has recovered. Additionally, no other issues were noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2017-00004 |
| MDR Report Key | 6799785 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2017-08-17 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-06-02 |
| Date Facility Aware | 2017-07-25 |
| Report Date | 2017-07-25 |
| Date Reported to Mfgr | 2017-07-25 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2016-12-27 |
| Date Added to Maude | 2017-08-17 |
| 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 | 2017-08-17 |
| Model Number | 820-5002-33 |
| Lot Number | 161227381 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 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 PK 1 SINGAPORE, 569620 SN 569620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-17 |