MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-10 for ARGYLE manufactured by Covidien Llc.
[67112419]
Patient Sequence No: 1, Text Type: N, H10
[67112420]
Umbilical artery catheter split at distal end next to hub, blood flowed from infant up catheter towards split and had to be removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6321682 |
| MDR Report Key | 6321682 |
| Date Received | 2017-02-10 |
| Date of Report | 2017-01-18 |
| Date of Event | 2016-12-20 |
| Report Date | 2017-01-10 |
| Date Reported to FDA | 2017-01-10 |
| Date Reported to Mfgr | 2017-01-10 |
| Date Added to Maude | 2017-02-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGYLE |
| Generic Name | CATHETER, UMBILICAL ARTERY |
| Product Code | GAZ |
| Date Received | 2017-02-10 |
| ID Number | DUAL LUMEN 3.5 FR |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Manufacturer Address | 15 HAMPSHIRE ST. MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-10 |