MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2001-08-17 for HEMOTECH MCFK60 KF15T manufactured by Medcomp.
[216847]
It was reported by the distributor that during the dialysis session the catheter became disconnected from the bloodline three times. Twice on the venous branch and once on the arterial branch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518902-2001-00156 |
| MDR Report Key | 348058 |
| Report Source | 01,08 |
| Date Received | 2001-08-17 |
| Date of Report | 2001-08-01 |
| Date of Event | 2001-07-16 |
| Date Mfgr Received | 2001-08-01 |
| Device Manufacturer Date | 2000-06-01 |
| Date Added to Maude | 2001-08-23 |
| 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 |
| Manufacturer Contact | RACHEL RICHARDSON |
| Manufacturer Street | 1499 DELP DRIVE |
| Manufacturer City | HARLEYSVILLE PA 19438 |
| Manufacturer Country | US |
| Manufacturer Postal | 19438 |
| Manufacturer Phone | 2152564201 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOTECH MCFK60 |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | LFK |
| Date Received | 2001-08-17 |
| Model Number | NA |
| Catalog Number | KF15T |
| Lot Number | M027360 |
| ID Number | NA |
| Device Expiration Date | 2001-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 337377 |
| Manufacturer | MEDCOMP |
| Manufacturer Address | 1499 DELP DR. HARLEYSVILLE PA 19438 US |
| Baseline Brand Name | MEDCOMP FEMORAL CATHETER |
| Baseline Model No | * |
| Baseline Catalog No | KF15T |
| Baseline ID | * |
| Baseline Device Family | FEMORAL CATHETER |
| 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 | 2001-08-17 |