MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-04 for HUDSON RCI ADAPTOR * manufactured by Teleflex Medical Hudson Rci.
[17397935]
The nipple and nut seemed to have separated as the christmas tree was screwed onto the flowmeter. This is a barbed oxygen concentrator adaptor made with a hex screw used to connect oxygen tubing to a diss female outlet on a concentrator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027977 |
| MDR Report Key | 2027977 |
| Date Received | 2011-03-04 |
| Date of Report | 2011-03-04 |
| Date of Event | 2011-03-04 |
| Report Date | 2011-03-04 |
| Date Reported to FDA | 2011-03-04 |
| Date Added to Maude | 2011-03-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | HUDSON RCI ADAPTOR |
| Generic Name | CHRISTMAS TREE ADAPTOR |
| Product Code | CAX |
| Date Received | 2011-03-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL HUDSON RCI |
| Manufacturer Address | 4042 STIRRUP CREEK DR SUITE 720 DURHAM, NC 27703 US 27703 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-04 |