MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-13 for CHAIT PERCUTANEOUS CECOSTOMY CATHETER N/A TDCS-100-M manufactured by Cook Inc.
[72948065]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[72948066]
International customer / patient reported that the clamp was broken resulting in leakage of water from the device. The device implant date was not provided. The leakage was observed in the connecting tube. The circumstances and handling conditions leading up to the event are not known. There are no reported adverse patient consequences. The device is not available for evaluation. This is one of two reports being submitted as the reporter / patient indicated two separate events. See mdr numbers 1820334-2017-00650 and 1820334-2017-00651 for each associated event.
Patient Sequence No: 1, Text Type: D, B5
[76264696]
Investigation? Evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications was conducted during the investigation. The complaint device was not returned; therefore, no physical examinations could be performed. However, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. A review of the device history record shows no nonconforming events which could contribute to this failure mode. It should be noted there were no other reported complaints for this lot number. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2017-00651 |
| MDR Report Key | 6490416 |
| Date Received | 2017-04-13 |
| Date of Report | 2017-05-22 |
| Date Mfgr Received | 2017-05-18 |
| Device Manufacturer Date | 2016-09-20 |
| Date Added to Maude | 2017-04-13 |
| 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. RITA HARDEN |
| 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 |
| Product Code | GCD |
| Date Received | 2017-04-13 |
| Model Number | N/A |
| Catalog Number | TDCS-100-M |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-04-13 |