MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-25 for POWER-TRIALYSIS SLIM-CATH STRAIGHT SHORT-TERM DIALYSIS CATHETER (12F) (TRIPLE-LU N/A 5853200J manufactured by Bard Access Systems.
[168050324]
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of recv0302 showed no other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[168050325]
It was reported that leakage from the catheter was found while using the power trialysis. There was no reported patient injury. On (b)(6) 2019 the facility reported that the initial information was incorrect and the correct event description was as below. (b)(6). It was reported that during insertion of the catheter, the catheter could not be advanced/withdrawn because the guidewire was stuck in the catheter. There was no reported patient injury. On 11/04/2019 - returned wire is unraveled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-03666 |
| MDR Report Key | 9370933 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-11-25 |
| Date of Report | 2019-11-25 |
| Date of Event | 2019-10-02 |
| Date Mfgr Received | 2019-11-04 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2019-11-25 |
| 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 | KELSEY ERICKSON |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225937 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWER-TRIALYSIS SLIM-CATH STRAIGHT SHORT-TERM DIALYSIS CATHETER (12F) (TRIPLE-LU |
| Generic Name | CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED |
| Product Code | NIE |
| Date Received | 2019-11-25 |
| Returned To Mfg | 2019-10-23 |
| Model Number | N/A |
| Catalog Number | 5853200J |
| Lot Number | RECV0302 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-25 |