MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-05-12 for CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET C-PTIS-100-HC manufactured by Cook, Inc..
[4448962]
A (b)(6) female patient underwent tracheostomy tube placement on (b)(6) 2014. After initial dilation with small dilator, the user exchanged for a blue rhino with white stylet. Upon advancement, it was noted that the wire and stylet were being seen side by side, which is not supposed to happen. Stylet was pulled back and it was noted ot be underneath posterior wall of the trachea rather than intraluminal. It is unclear as to when the stylet perforated the posterior trachea wall. Patient is stable, and scheduled for surgery within the next 1-2 days. According to the initial reporter, the patient did not experience any adverse effect due to this occurence.
Patient Sequence No: 1, Text Type: D, B5
[11888509]
(b)(4). Event is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2014-00215 |
| MDR Report Key | 3818090 |
| Report Source | 06 |
| Date Received | 2014-05-12 |
| Date of Report | 2014-04-25 |
| Date of Event | 2014-04-25 |
| Date Facility Aware | 2014-04-25 |
| Report Date | 2014-04-25 |
| Date Mfgr Received | 2014-04-25 |
| Device Manufacturer Date | 2014-02-18 |
| Date Added to Maude | 2014-05-20 |
| 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, DIRECTOR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47402 |
| Manufacturer Country | US |
| Manufacturer Postal | 47402 |
| 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 | KCG DILATOR, TRACHEAL |
| Product Code | KCG |
| Date Received | 2014-05-12 |
| Model Number | NA |
| Catalog Number | C-PTIS-100-HC |
| Lot Number | 4784987 |
| ID Number | NA |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-12 |