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 2017-07-11 for HARMONY A.V.FISTULA 15GX1" BE 30CM W/CLAMP 827-1500-33 manufactured by Jms Singapore Pte Ltd.
[79732185]
(b)(4). Fresenius medical care report dated on (b)(6) 2017. 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 suture on the access site administered on patient in the emergency department. Jmss had 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 (b)(4) latest 15g harmony product lots provided by the clinic, there was no abnormality found. The products met the qa specifications prior releasing it to the market. There was no reported or detected malfunction on the needle itself and this was re-confirmed twice by initial reporter. Although actual sample involved in the event is unavailable for evaluation, we have determined the actual case of the reported incident to be end-use error, we did due diligence and investigated the (b)(4) latest 15g harmony product lots, in an effort to further substantiate that there is no abnormality observed in our products. Based on the information provided by registered nurse, there was no abnormality on the needle. The needle dislodged as the patient had failed to properly secure the needle as he had been taught to do using the chevron/ butterfly piece of tape and an additional piece with gauze to cover the access site. The specific injury that required a suture was caused by patient re-inserting needle in an attempt to resume dialysis treatment after the venous needle dislodgement occurred. Causal analysis reveals that the reported adverse event incidents are due to patient's failure to conduct his treatment as he had been taught and done properly for the past 2 1/2 years which is contrary to protocols, recommended guidelines and patient's previous training.
Patient Sequence No: 1, Text Type: N, H10
[79732186]
Registered nurse reported that the patient placed only gauze over the needle site, without tape, and the needle dislodged during treatment. The patient attempted to reposition the needle but was unsuccessful and terminated the treatment. The patient then failed to apply pressure to the site and continued to bleed. The patient required a suture on the site in the emergency department. The patient lost over around 100ml blood and the extracorporeal circuit was wasted. The needle fell out and the patient did not apply pressure allowing for additional blood loss (100ml estimated blood loss is 100cc). The patient did not know why he had done this. He attempted to re-insert a venous needle and was unable to do so. He went to the emergency room and upon arrival, he stated that he was bleeding. He told the emergency staff that he was supposed to put pressure on it. The patient did not require any further treatment in the emergency room than the suture. He is doing well now. The nurse stated that the patient might have done a little damage when he was attempting to place a second venous needle which leads to an abrasion. Hence, the patient has to seek medical care in the emergency care in the hospital. He did use a single piece of paper tape across the wings of the needle but he did not secure it the rest of the way as he had been instructed to with a butterfly/ chevron and additional tape over the site. The nurse stated that the patient is very hairy and often has to use additional tape to secure the needles. Venous needle dislodged, approximate blood loss is 100cc. Fistula is located in the left lower arm. Patient utilize 15g harmony needle. The patient lives with his mother and performs his own dialysis. He has been on dialysis for nearly 3 years. He has been a home patient for the past 2 1/2 years and has been trained on proper insertion, taping and removal of his buttonhole needles. The nurse said that they could not understand why the patient did this as it was not like him. They will be reinforcing proper set up and care during treatment as well as removal and post care with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2017-00003 |
| MDR Report Key | 6704870 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2017-07-11 |
| Date of Report | 2017-06-17 |
| Date of Event | 2017-06-09 |
| Date Facility Aware | 2017-06-09 |
| Report Date | 2017-06-17 |
| Date Reported to Mfgr | 2017-06-17 |
| Date Mfgr Received | 2017-06-17 |
| Date Added to Maude | 2017-07-11 |
| 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 | 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 | 24933 |
| Manufacturer Country | ID |
| Manufacturer Postal Code | 24933 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HARMONY A.V.FISTULA 15GX1" BE 30CM W/CLAMP |
| Generic Name | JMS HARMONY A.V.FISTULA NEEDLE SET |
| Product Code | FIE |
| Date Received | 2017-07-11 |
| Model Number | 827-1500-33 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-07-11 |