MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT (13F) (12.5CM) N/A 5613120 manufactured by Bard Access Systems.
[181180632]
The device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility. A lot history review (lhr) of redp1857 showed no other similar product complaint(s) from this lot number. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181180633]
It was reported via received medwatch that the "doctor was placing bd cath on patient. Upon removal of the guide wire the inner part of wire was removed while the outer coil peeled away apparently broke off inside the patient. This was visualized on post line chest x-ray. The original catheter initially gave blood return but after placement there was no blood return. This catheter was removed and another was inserted without issue. Repeat x-ray still showed wire so a ct scan of chest was done and patient was scheduled to go to the cath lab for removal of wire"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00625 |
| MDR Report Key | 9756957 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-20 |
| Date Facility Aware | 2020-01-20 |
| Report Date | 2020-01-28 |
| Date Reported to FDA | 2020-01-28 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-02-01 |
| Date Added to Maude | 2020-02-26 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 CURVED EXTENSION DIALYSIS CATHETER KIT (13F) (12.5CM) |
| Generic Name | CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED |
| Product Code | NIE |
| Date Received | 2020-02-26 |
| Model Number | N/A |
| Catalog Number | 5613120 |
| Lot Number | REDP1857 |
| 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. Required No Informationntervention | 2020-02-26 |