MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-28 for HUDSON RCI IPN044768 5-10316 manufactured by Teleflex Medical.
[112592812]
Staff has had the ett fortlight adapters popping out issue rear its ugly head again. There were 2 patients in the cvicu today who had an issue. The tubes remain in.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7645555 |
| MDR Report Key | 7645555 |
| Date Received | 2018-06-28 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-06-14 |
| Report Date | 2018-06-18 |
| Date Reported to FDA | 2018-06-18 |
| Date Reported to Mfgr | 2018-06-28 |
| Date Added to Maude | 2018-06-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | HUDSON RCI |
| Generic Name | TUBE, TRACHEAL |
| Product Code | BYX |
| Date Received | 2018-06-28 |
| Model Number | IPN044768 |
| Catalog Number | 5-10316 |
| Lot Number | N/A |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-28 |