MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-04-14 for CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET C-PTISY-100-HC manufactured by Cook, Inc..
[1049631]
A male patient had a percutaneous trach placed at bedside. The next day, the nurse noticed that the phalange was broken on each side of the trach, and notified the surgeon and the pulmonary physician. The surgeon was in the pt's room within the hour and removed the trach and orally intubated the pt. Pt outcome unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
[8327144]
Event evaluation: still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2009-00175 |
| MDR Report Key | 1365260 |
| Report Source | 05,06,07 |
| Date Received | 2009-04-14 |
| Date of Report | 2009-03-16 |
| Date of Event | 2009-03-04 |
| Date Facility Aware | 2009-03-04 |
| Report Date | 2009-03-16 |
| Date Mfgr Received | 2009-03-16 |
| Device Manufacturer Date | 2008-05-19 |
| Date Added to Maude | 2009-04-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, MANAGER |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET |
| Generic Name | DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
| Product Code | KCG |
| Date Received | 2009-04-14 |
| Catalog Number | C-PTISY-100-HC |
| Lot Number | 2097024-1 |
| Device Expiration Date | 2009-04-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-04-14 |