MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-10 for CXI SUPPORT CATHETER G23162 CXI-2.3-14-135-ANG manufactured by Cook Inc.
[182922786]
Occupation = unknown. Pma/510(k) number = k122796. Device evaluated by mfg: device evaluation has begun; however, a conclusion is not yet available. 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
[182922787]
As reported, prior to an unknown procedure, the tip of a cxi support catheter bent and nearly separated upon removal from the packaging. The initial reporter stated the device was stuck inside the plastic tubing of the packaging material, requiring additional force to remove it. On return inspection of the device 06mar2020, the catheter tip was kinked with partial separation of 3mm in length. The device did not make patient contact. A section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence. The patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00580 |
| MDR Report Key | 9810734 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2020-01-14 |
| Date Added to Maude | 2020-03-10 |
| 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 | CXI SUPPORT CATHETER |
| Generic Name | KRA CATHETER, CONTINUOUS FLUSH |
| Product Code | KRA |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-03-06 |
| Model Number | G23162 |
| Catalog Number | CXI-2.3-14-135-ANG |
| Lot Number | 10264232 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-10 |