MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for CIAGLIA BLUE RHINO G2 manufactured by Cook Medical Ll.
[135708638]
On (b)(6) 2018 attempted percutaneous trach at bedside. The white guidewire slid past the notch while attempting dilation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8306682 |
| MDR Report Key | 8306682 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-11-30 |
| Date Facility Aware | 2018-11-30 |
| Report Date | 2018-12-13 |
| Date Reported to FDA | 2018-12-13 |
| Date Reported to Mfgr | 2018-12-13 |
| Date Added to Maude | 2019-02-05 |
| 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 | RISK MANAGER |
| 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 | 0 |
| Brand Name | CIAGLIA BLUE RHINO G2 |
| Generic Name | TRACHOSTOMY KIT |
| Product Code | KCG |
| Date Received | 2018-12-17 |
| Lot Number | 8915391 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL LL |
| Manufacturer Address | BLOOMINGTON IN 474024195 US 474024195 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-17 |