MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for COVIDIEN UMBILICAL VESSEL CATHETER ARGYLE POLYURETHANE 3.5 FR manufactured by Covidien Manufacturing Solutions Sa.
[176575478]
Uac bp waveform noted to be dampened, attempted to flush line and pull back and it was noted to be very difficult to flush / pullback blood. Iv fluids and transducer replaced by this rn. Line with no change in status. Umbilical line removed by neonatologist. Catheter appeared to have a small hole near tip of catheter. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092509 |
| MDR Report Key | 9632291 |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-17 |
| Date Added to Maude | 2020-01-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | COVIDIEN UMBILICAL VESSEL CATHETER |
| Generic Name | CATHETER, UMBILICAL ARTERY |
| Product Code | FOS |
| Date Received | 2020-01-24 |
| Model Number | ARGYLE POLYURETHANE |
| Catalog Number | 3.5 FR |
| Lot Number | 1904300070 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MANUFACTURING SOLUTIONS SA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-24 |