MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER N/A UNKNOWN manufactured by Bard Access Systems.
[184750229]
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[184750230]
It was reported via ms&s, "nurse practitioner states she placed a trialysis in the left ij "low stick" brachial cephalic that perforated the main pulmonary artery resulting in patient going to or for sternotomy. Np asking if this is a common occurence with trialysis. Np unsure if trialysis was retained by hospital. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00912 |
| MDR Report Key | 9857024 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-19 |
| 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 SHORT-TERM DIALYSIS CATHETER |
| Generic Name | CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED |
| Product Code | NIE |
| Date Received | 2020-03-19 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Life Threatening; 2. Required No Informationntervention | 2020-03-19 |