MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 1999-04-29 for UNIVERSAL CAVH CATHETER MCT-106 manufactured by Medcomp.
[174181]
The risk mgr reported that the catheter was inserted into the right femoral artery. The catheter was cracked, which induced bleeding. The pt lost approx 400cc of blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518902-1999-00050 |
| MDR Report Key | 221335 |
| Report Source | 00,05,06 |
| Date Received | 1999-04-29 |
| Date of Report | 1999-04-05 |
| Date of Event | 1999-03-25 |
| Date Mfgr Received | 1999-03-30 |
| Device Manufacturer Date | 1998-05-01 |
| Date Added to Maude | 1999-05-04 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL CAVH CATHETER |
| Generic Name | ARTERIAL CAVH CATHETER |
| Product Code | LFK |
| Date Received | 1999-04-29 |
| Model Number | NA |
| Catalog Number | MCT-106 |
| Lot Number | M816540 |
| ID Number | NA |
| Device Expiration Date | 2000-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 214630 |
| Manufacturer | MEDCOMP |
| Manufacturer Address | 1499 DELP DR. HARLEYSVILLE PA 19438 US |
| Baseline Brand Name | UNIVERSAL CAVH CATHETER |
| Baseline Generic Name | 8F 6" CAVH STRAIGHT CAVH CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | MCT-106 |
| Baseline ID | 8F X 6" (15CM) |
| Baseline Device Family | MEDCOMP DOUBLE LUMEN HEMO-CATH |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 31 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K862771 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1999-04-29 |