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..
[15884618]
Lot number not provided by the reporter. Expiration date unk as lot is unk. Perforation is not labeled. Trauma to the posterior trachea wall is mentioned in the ifu. Event is not reportable under (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[15935246]
A (b)(6) female pt underwent tracheostomy tube placement on (b)(6) 2014. After initial dilation with small dilator, which was difficult but successful, the user exchanged for a blue rhino and inserted 8mm bivona tts. Upon confirmation it was clear that the stylet was not intraluminal. It was noted that there was a rent in the posterior tracheal wall. It is unclear as to when the stylet perforated the posterior trachea wall. Pt is stable. Tracheal tube was passed below level of injury. Observing for 1 week for healing of perforation. According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2014-00214 |
| MDR Report Key | 3836021 |
| Report Source | 06 |
| Date Received | 2014-05-12 |
| Date of Report | 2014-04-25 |
| Date of Event | 2014-04-24 |
| Date Facility Aware | 2014-04-25 |
| Report Date | 2014-04-25 |
| Date Mfgr Received | 2014-04-25 |
| Date Added to Maude | 2014-05-29 |
| 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 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 | KCG DILATOR, TRACHEAL |
| Product Code | KCG |
| Date Received | 2014-05-12 |
| Model Number | NA |
| Catalog Number | C-PTIS-100-HC |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| 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. Other; 2. Required No Informationntervention | 2014-05-12 |