MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-29 for BUDGET MEDICAL - ICU MEDICAL * manufactured by Budget Medical.
[321228]
Used t-connector for an arterial line on a pt. T-connector was found to have a clot formation. Further discussion with physician indicated that staff have been using t-connector in this manner (as an arterial line connector) when neither the packaging nor the manufacturer had indicated not to use the device in this manner. Physician is afraid a less experienced md will not notice the clotting and flush the line into an artery, embolizing a clot, potentially causing stroke and for death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029162 |
| MDR Report Key | 475473 |
| Date Received | 2003-07-29 |
| Date of Report | 2003-07-14 |
| Date of Event | 2003-06-27 |
| Date Added to Maude | 2003-08-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUDGET MEDICAL - ICU MEDICAL |
| Generic Name | T-CONNECTOR PED WITH VALVE |
| Product Code | FKB |
| Date Received | 2003-07-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 464319 |
| Manufacturer | BUDGET MEDICAL |
| Manufacturer Address | 951 CALLE AMANECER SAN CLEMENTE CA 92673 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-07-29 |