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 1997-02-28 for HEMOTECH MCFK60 KF15T * manufactured by Medcomp.
[18480738]
"when the dr try and get out the guidewire, during the insertion of the catheter, it has been very difficult, as if some spirals of the guidewire were jammed at the top of the needle".
Patient Sequence No: 1, Text Type: D, B5
[21474253]
4/14/97 co has requested additional information from this foreign distributor 3 times and none has been forthcoming. Due to this, co would like to close this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518902-1997-00006 |
| MDR Report Key | 74968 |
| Report Source | 01,05,08 |
| Date Received | 1997-02-28 |
| Date of Report | 1997-01-31 |
| Date of Event | 1997-01-29 |
| Date Facility Aware | 1997-02-28 |
| Date Reported to Mfgr | 1997-01-31 |
| Device Manufacturer Date | 1996-07-01 |
| Date Added to Maude | 1997-03-12 |
| 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 | HEMOTECH MCFK60 |
| Generic Name | HEMODIALYSIS INSERTION SET AND CATHETER |
| Product Code | LFK |
| Date Received | 1997-02-28 |
| Model Number | KF15T |
| Catalog Number | * |
| Lot Number | M614520 |
| ID Number | * |
| Device Expiration Date | 2001-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 74759 |
| 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 | 1997-02-28 |