MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-23 for ARGON MEDICAL DEVICES 498107 manufactured by Argon Medical Devices, Inc..
[6191430]
Pt had arterial line placed in left radial in the operating room on (b)(6) 2015, which functional uneventfully during the surgical procedure. Approx 4 hours post-operatively, the waveform was noted to be flat, with no bp reading. Dressing was removed, sutures intact. When removing the arterial line, only the hub came out. The actual catheter was retained in the pts' wrist. Pt was taken back to surgery on (b)(6) 2015 for removal of the retained portion of the arterial line.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5044791 |
| MDR Report Key | 4945816 |
| Date Received | 2015-07-23 |
| Date of Report | 2015-07-09 |
| Date of Event | 2015-06-23 |
| Date Added to Maude | 2015-07-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGON MEDICAL DEVICES |
| Generic Name | ARTERIAL CATHETER MINI KIT |
| Product Code | FTN |
| Date Received | 2015-07-23 |
| Model Number | 498107 |
| Catalog Number | 498107 |
| Lot Number | 11096177 |
| Device Expiration Date | 2020-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES, INC. |
| Manufacturer Address | ATHENS TX US |
| Brand Name | ARGON MEDICAL DEVICES |
| Generic Name | ARTERIAL CATHETER MINI KIT |
| Product Code | FTN |
| Date Received | 2015-07-23 |
| Model Number | 498107 |
| Catalog Number | 498107 |
| Lot Number | 11098879 |
| Device Expiration Date | 2020-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES, INC. |
| Manufacturer Address | ATHENS TX US |
| Brand Name | ARGON MEDICAL DEVICES |
| Generic Name | ARTERIAL CATHETER MINI KIT |
| Product Code | FTN |
| Date Received | 2015-07-23 |
| Model Number | 498107 |
| Catalog Number | 498107 |
| Lot Number | 11096973 |
| Device Expiration Date | 2020-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES, INC. |
| Manufacturer Address | ATHENS TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-23 |