MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-03 for CHAIT PERCUTANEOUS CECOSTOMY CATHETER TDCS-100-M manufactured by Cook, Inc..
[909372]
Catheter was placed in 2008. On approx one and a half months later, patient called the facility to notify them that the catheter had broke just below the hub, in the tubing. The pt requested not to have another chait catheter placed. A foley catheter was placed instead of the chait catheter. Patient is doing well with the new catheter.
Patient Sequence No: 1, Text Type: D, B5
[8194275]
Unknown as the lot number was not provided by reporter. No product was returned to assist us in this investigation. Unfortunately, without the actual complaint device, we are unable to determine with certainty, how/why this event may have occurred. The appropriate individual have been notified. We will continue to monitor for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2008-00484 |
| MDR Report Key | 1149470 |
| Report Source | 05 |
| Date Received | 2008-09-03 |
| Date of Report | 2008-08-04 |
| Date of Event | 2008-08-04 |
| Date Facility Aware | 2008-08-04 |
| Report Date | 2008-08-04 |
| Date Mfgr Received | 2008-08-04 |
| Date Added to Maude | 2008-11-22 |
| 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, MANAGER |
| 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 | CHAIT PERCUTANEOUS CECOSTOMY CATHETER |
| Generic Name | EXD IRRIGATOR, OSTOMY |
| Product Code | EXD |
| Date Received | 2008-09-03 |
| Model Number | NA |
| Catalog Number | TDCS-100-M |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1290444 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-03 |