MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-23 for FLEXOR CHECK FLO INTRODUCER SET KCFW603845RB manufactured by Cook Medical.
[98232980]
Flexor sheath inserted into right femoral artery, sheath came apart. Hub came detached from sheath body.
Patient Sequence No: 1, Text Type: D, B5
[103328725]
Add'l info received on 03/16/2018 for report #mw5074769: this is an amended report due to listing incorrect mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074769 |
| MDR Report Key | 7214940 |
| Date Received | 2018-01-23 |
| Date of Report | 2017-12-29 |
| Date of Event | 2017-10-03 |
| Date Added to Maude | 2018-01-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 0 |
| Brand Name | FLEXOR CHECK FLO INTRODUCER SET |
| Generic Name | CATHETER INTRODUCER KIT |
| Product Code | OFC |
| Date Received | 2018-01-23 |
| Catalog Number | KCFW603845RB |
| Lot Number | 8105915 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-23 |