MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-10-25 for TENCKHOFF SPIRAL CHRONIC PERITONEAL DIALYSIS CATHETER SET N/A C-TCPS-15-41-78-SPRL-14-6 manufactured by Cook Inc.
[90987293]
(b)(4). No known impact or consequence to patient. 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
[90987294]
The customer reported that the tenckhoff spiral chronic peritoneal dialysis catheter would not flush with fluid. Another catheter was opened to complete the procedure, with no further product issues reported. The customer confirmed that no additional procedures were necessitated and no patient adverse events occurred due to the issue. Additional information was requested but could not be provided by the reporter. The product is reportedly unavailable for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-03649 |
| MDR Report Key | 6976256 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-10-25 |
| Date of Report | 2018-03-20 |
| Date Mfgr Received | 2018-02-20 |
| Device Manufacturer Date | 2017-07-05 |
| Date Added to Maude | 2017-10-25 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TENCKHOFF SPIRAL CHRONIC PERITONEAL DIALYSIS CATHETER SET |
| Product Code | GBW |
| Date Received | 2017-10-25 |
| Model Number | N/A |
| Catalog Number | C-TCPS-15-41-78-SPRL-14-6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-10-25 |