MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-26 for COOK CHEST DRAIN VALVE G36370 C-CDV-1 manufactured by Cook Inc.
[185316762]
Pma/510(k): exempt. 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
[185316763]
It was reported that a cook chest drain valve was found to be leaking during preparation. The device leaks out of the blue end and "drip[s] all over the patient". Per the district manager, the blue end of the valve should be connected to the tubing, not open. It is unclear at this time how the device was connected during this event. The procedure was completed without a valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00688 |
| MDR Report Key | 9882576 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2020-01-28 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| Model Number | G36370 |
| Catalog Number | C-CDV-1 |
| Lot Number | 10293356 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-26 |