MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-06-10 for CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY C-PTISY-100-HC-PERC8 manufactured by Cook Inc.
[20312998]
Patient had a #8 trach put in at bedside (b)(6) 2010. Outer cannula of trach was broken away from plate. Trach could not slide in or out of the orifice. Held trach in place and called trauma physician. Patient went to operating room to have trach replaced. Since new trach, patient has been fine.
Patient Sequence No: 1, Text Type: D, B5
[20578913]
Expiration - unknown as lot is unknown. (b)(4). The complaint device was returned in a contaminated and used condition. Upon examination of the device, it was confirmed that the flange had separated from the tracheostomy tube. Instructions for use (ifu) details appropriate placement and usage techniques. Appropriate design control activities have been completed in relation to this product line. The tracheostomy tube is supplied by an approved vendor. The vendor has been notified of these types of complaints. He stated that an updated fixture was implemented in relation to this issue in september 2009, and that pull tests are performed in-process to confirm the units are holding as specified. Additionally, he informed us that historically they receive approximately 10 complaints per million relating to this failure mode. Upon examination of the product, the tracheostomy tube was confirmed to be separated from the flange. The shiley lot number involved in this incident is 0811000137, which was recently recalled due to issues with the pilot balloon assembly. The cook inc. Lot number was not provided. The component vendor has been notified in regards to this failure mode. We will continue to monitor for similar complaints. Appropriate individuals have been notified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2010-00258 |
| MDR Report Key | 1725280 |
| Report Source | 05,07 |
| Date Received | 2010-06-10 |
| Date of Report | 2010-05-11 |
| Date of Event | 2010-04-12 |
| Date Facility Aware | 2010-04-12 |
| Report Date | 2010-05-11 |
| Date Mfgr Received | 2010-05-11 |
| Date Added to Maude | 2010-06-18 |
| 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 |
| Health Professional | 3 |
| 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 TRAY |
| Generic Name | KCG DILATOR, TRACHEAL |
| Product Code | KCG |
| Date Received | 2010-06-10 |
| Returned To Mfg | 2010-05-18 |
| Model Number | NA |
| Catalog Number | C-PTISY-100-HC-PERC8 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2010-06-10 |