MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-01 for ARTERIAL LINE KIT 498411B manufactured by Argon Medical Devices Inc..
[137953097]
The investigation is ongoing and a follow up report will be submitted once the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[137953098]
Patient has had an arterial line inserted in to the left radial artery on (b)(6) 2019. On (b)(6) 2019 patient's arm needed a dressing change. When the nurse was about to do the dressing change she noticed the arterial line had only about 1cm of cannula left and was hanging by the tape. Doctor was notified and was able to use the sonosite to confirm part of the catheter was remaining in the patient? S artery. Doctor stated ir needed to see the patient to remove the remaining cannula from her arm. On (b)(6) 2019 artline placed in operating room. Broke off in similar location to previous one in the icu. Previous artline was placed in the operating room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2019-00034 |
| MDR Report Key | 8382204 |
| Date Received | 2019-03-01 |
| Date of Report | 2019-02-01 |
| Date of Event | 2019-01-31 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2005-01-14 |
| Device Manufacturer Date | 2018-12-14 |
| Date Added to Maude | 2019-03-01 |
| 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. GAIL SMITH |
| Manufacturer Street | 1445 FLAT CREEK ROAD |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal | 75751 |
| Manufacturer Phone | 2144368995 |
| Manufacturer G1 | ARGON MEDICAL DEVICES INC. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARTERIAL LINE KIT |
| Generic Name | ARTERIAL LINE |
| Product Code | GDF |
| Date Received | 2019-03-01 |
| Returned To Mfg | 2019-02-14 |
| Catalog Number | 498411B |
| Lot Number | 11241437 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-01 |