MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-25 for COOK CHEST DRAIN VALVE N/A C-CDV-1 manufactured by Cook Inc.
[183159651]
(b)(6). Occupation: unknown. Pma/510(k) #: exempt. (b)(4). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[183159652]
It was reported that fluid from the patient was returning into a cook chest drain valve. As a result, the patient experienced "pulmonary expansion". The device was used both inside and outside of a healthcare facility during its implantation. During the patient's follow-up, it was noted that the valve was not waterproof. A presence of serious fluid and fibrin debris from the thorax was reported to have collected inside of the valve, which allowed the entry of air into the patient's thorax. This was validated by "immersion in water", which "went up in inspiration towards the pleural space". Additionally, there was a presence of clots obstructing the valve. No other adverse effects to the patient have been reported. Additional information regarding the patient and event has been requested but is currently unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00451 |
| MDR Report Key | 9750600 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-02-25 |
| 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 | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CHEST DRAIN VALVE |
| Generic Name | JOL CATHETER AND TIP, SUCTION |
| Product Code | JOL |
| Date Received | 2020-02-25 |
| Model Number | N/A |
| Catalog Number | C-CDV-1 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |