MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for AIRLIFE OXYGEN TUBING 00130 manufactured by Vyaire Medical, Inc..
[177380088]
Nurse noticed the tubing leaking at the same connection site at the green cuff, where the clear tubing initially meets the cuff site. Oxygen was leaking profusely from that site and the tubing was replaced with a new set.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9659276 |
| MDR Report Key | 9659276 |
| Date Received | 2020-02-03 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-12-26 |
| Report Date | 2020-01-03 |
| Date Reported to FDA | 2020-01-03 |
| Date Reported to Mfgr | 2020-02-03 |
| Date Added to Maude | 2020-02-03 |
| 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 | 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 | AIRLIFE OXYGEN TUBING |
| Generic Name | CANNULA, NASAL, OXYGEN |
| Product Code | CAT |
| Date Received | 2020-02-03 |
| Model Number | 00130 |
| Lot Number | 0004100451 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC. |
| Manufacturer Address | 26125 NORTH RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |