MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-04-08 for 5.0FR URETHANE UMB CATH 8888160341 manufactured by Covidien.
[141345135]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[141345136]
The customer reported the umbilical artery catheter was placed by a nurse practitioner and a registered nurse (rn) connected fluids to the newly placed line. Shortly after initiating fluids, blood was noted to be backing up into the umbilical line. The rn noticed immediately and visualized a slow fluid leak from the umbilical catheter near the hub of the catheter. The line was clamped and the healthcare provider was notified. The line was removed and a new catheter was placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00654 |
| MDR Report Key | 8493092 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-04-08 |
| Date of Report | 2019-08-05 |
| Date Mfgr Received | 2019-04-03 |
| Date Added to Maude | 2019-04-08 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524970 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | EDIFICIO B20 CALLE #2 ZONA FRA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5.0FR URETHANE UMB CATH |
| Generic Name | CATHETER, UMBILICAL ARTERY |
| Product Code | FOS |
| Date Received | 2019-04-08 |
| Model Number | 8888160341 |
| Catalog Number | 8888160341 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | EDIFICIO B20 CALLE #2 ZONA FRA ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |