MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-25 for MEDCOMP 14GA X 13.3CM FEMORAL CATHETER MCFK64 manufactured by Medical Components.
[22070799]
Pt had a mcfk64 catheter inserted 5/28/1998 for dialysis treatment and during removal after the treatment when the catheter broke and approximately 3" of the distal tip remained in the pt. The pt was transferred to vascular service. The fragment was isolated in the femoral vein and the doctor removed it. The pt was cooperative and complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 174465 |
| MDR Report Key | 174465 |
| Date Received | 1998-06-25 |
| Date of Report | 1998-06-25 |
| Date of Event | 1998-05-28 |
| Date Facility Aware | 1998-05-28 |
| Report Date | 1998-06-25 |
| Date Added to Maude | 1998-06-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDCOMP 14GA X 13.3CM FEMORAL CATHETER |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | LFK |
| Date Received | 1998-06-25 |
| Returned To Mfg | 1998-05-28 |
| Model Number | NA |
| Catalog Number | MCFK64 |
| Lot Number | M808480 |
| ID Number | NA |
| Device Expiration Date | 2003-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | .12 DAY |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 169627 |
| Manufacturer | MEDICAL COMPONENTS |
| Manufacturer Address | 1499 DELP DR. HARLEYSVILLE PA 19438 US |
| Baseline Brand Name | 14GA X 5 1/4" FEMORAL CATHETER |
| Baseline Generic Name | 14GA FEMORAL CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | MCFK64 |
| Baseline ID | 14GA X 13.3CM S |
| Baseline Device Family | MEDCOMP SINGLE LUMEN HEMO-CATH |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K860810 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-06-25 |