MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-25 for AIRLIFE, TRI-FLO * 4897T manufactured by Cardinal Health.
[16030134]
Nurse and respiratory therapist were attempting to suction the endotracheal tube of an infant on a ventilator with the suction catheter. When they passed the catheter into the et tube and covered the port to apply suction it was found that the catheter was not patent. There was a blockage within the catheter that made it defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1074464 |
| MDR Report Key | 1074464 |
| Date Received | 2008-06-25 |
| Date of Report | 2008-06-25 |
| Date of Event | 2008-06-18 |
| Report Date | 2008-06-25 |
| Date Reported to FDA | 2008-06-25 |
| Date Added to Maude | 2008-07-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE, TRI-FLO |
| Generic Name | KIT, SUCTION |
| Product Code | OFR |
| Date Received | 2008-06-25 |
| Model Number | * |
| Catalog Number | 4897T |
| Lot Number | Y08D1096 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1041313 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN ROAD MCGAW PARK, IL 600856787 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-25 |