MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 1997-10-10 for MEDCOMP FEMORAL CATHETER * MCFK60/KF15YT manufactured by Medcomp.
[112803]
During dialysis, (unipuncture within the femoral vein), coagulation of the whole extracorporeal circuit after 20 minutes of dialysis. Change of the lines and the dialyzer, 1 hour later, second coagulation. Stop treatment, the catheter has been taken out and it has not been possible to inject any liquid through the arterial way, the venous way being clamped. Transfusion of 3 red cell concentrate units necessary as well as a dialysis in emergency 2 hours later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518902-1997-00042 |
| MDR Report Key | 125988 |
| Report Source | 01,05,08 |
| Date Received | 1997-10-10 |
| Date of Report | 1997-09-10 |
| Date of Event | 1997-08-12 |
| Date Facility Aware | 1997-08-12 |
| Report Date | 1997-10-10 |
| Date Mfgr Received | 1997-09-10 |
| Device Manufacturer Date | 1997-03-01 |
| Date Added to Maude | 1997-10-15 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDCOMP FEMORAL CATHETER |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | LFK |
| Date Received | 1997-10-10 |
| Model Number | * |
| Catalog Number | MCFK60/KF15YT |
| Lot Number | M705940 |
| ID Number | * |
| Device Expiration Date | 2000-03-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 123316 |
| Manufacturer | MEDCOMP |
| Manufacturer Address | 1499 DELP DR. HARLEYSVILLE PA 19438 US |
| Baseline Brand Name | MEDCOMP FEMORAL CATHETER |
| Baseline Generic Name | HEMODIALYSIS CATHETER |
| Baseline Model No | * |
| Baseline Catalog No | MCFK60/KF15YT |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-10-10 |