MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for ARGYLE 8888160432 manufactured by Cardinal Health, Inc..
[146067591]
Umbilical artery catheter placed in infant. Ivfs attached and transducing appropriate waveform and bp. Lab drawn from uac at stopcock connection without incidence. Good blood return. Flushed easily. Approximately 20 minutes later, line began to back up blood and noted leaking from a crack in line near hub. Line clamped to prevent blood loss. Md notified. Catheter removed by md and replaced with new umbilical catheter. Catheter saved for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8640018 |
| MDR Report Key | 8640018 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-04-29 |
| Report Date | 2019-05-16 |
| Date Reported to FDA | 2019-05-16 |
| Date Reported to Mfgr | 2019-05-24 |
| Date Added to Maude | 2019-05-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | FOS |
| Date Received | 2019-05-24 |
| Model Number | 8888160432 |
| Catalog Number | 8888160432 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH, INC. |
| Manufacturer Address | 7000 CARDINAL PLACE DUBLIN OH 43017 US 43017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-24 |