MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-04-25 for CONNECTING TUBE WITH DRAINAGE BAG CONNECTOR CTU14.0-30-ST manufactured by Cook, Inc..
[456824]
The connecting tube was attached to a catheter for treatment of a pnemothorax of the left lung in 2006. The pt only had 1/3 of the right lung present. Some time in the evening after placement of the tube, the stopcock separated from the tube. The tubing was then clamped and subsequently replaced. The pt suffered no adverse effect from this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2006-00085 |
| MDR Report Key | 704010 |
| Report Source | 05,07 |
| Date Received | 2006-04-25 |
| Date of Report | 2006-03-27 |
| Date of Event | 2006-03-22 |
| Date Facility Aware | 2006-03-22 |
| Report Date | 2006-03-27 |
| Date Mfgr Received | 2006-03-27 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2006-04-27 |
| 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 |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONNECTING TUBE WITH DRAINAGE BAG CONNECTOR |
| Generic Name | DRAINAGE |
| Product Code | BYH |
| Date Received | 2006-04-25 |
| Returned To Mfg | 2006-03-27 |
| Model Number | NA |
| Catalog Number | CTU14.0-30-ST |
| Lot Number | 1562832 |
| ID Number | * |
| Device Expiration Date | 2009-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 693106 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US |
| Baseline Brand Name | CONNECTING TUBE WITH DRAINAGE BAG CONNECTOR |
| Baseline Generic Name | DRAINAGE |
| Baseline Model No | NA |
| Baseline Catalog No | CTU14.0-30-ST |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-04-25 |