MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-05-12 for FEM-FLEX FEMORAL CANNULA * TFA-024-25 manufactured by Research Medical, Inc..
[54364]
Following insertion of the cannula, when the cap was being placed, the ccp noticed the luer portion of the t-connector was cracked. The cannula was used for remainder of procedure with no adverse impact to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713910-1997-00009 |
| MDR Report Key | 92351 |
| Report Source | 05 |
| Date Received | 1997-05-12 |
| Date of Report | 1997-05-09 |
| Date of Event | 1997-04-16 |
| Date Mfgr Received | 1997-05-06 |
| Device Manufacturer Date | 1996-08-01 |
| Date Added to Maude | 1997-05-23 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEM-FLEX FEMORAL CANNULA |
| Generic Name | FEMORAL ARTERIAL CANNULA |
| Product Code | LFK |
| Date Received | 1997-05-12 |
| Model Number | * |
| Catalog Number | TFA-024-25 |
| Lot Number | 88404 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 91219 |
| Manufacturer | RESEARCH MEDICAL, INC. |
| Manufacturer Address | 6864 SOUTH 300 WEST MIDVALE UT 84047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 1997-05-12 |