FDA Adverse Event
Malfunction
Summary report: N
CLAVE NEEDLELESS CONNECTOR
MDR report key: 279726
·
Received May 25, 2000
Report
- Report Number
- MW1019007
- Event Type
- Malfunction
- Date Received
- May 25, 2000
- Date of Event
- April 27, 2000
- Report Date
- May 15, 2000
- Manufacturer
- ICU MEDICAL, INC.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PAIN MANAGEMENT RECOVERY ROOM LPN NOTED BACK FLOW OF BLOOD FROM CLAVE NEEDLELESS CONNECTOR. LPN REMOVED THE DEVICE FROM THE PT'S ARM AND APPLIED PRESSURE. NO ADVERSE OUTCOME TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLAVE NEEDLELESS CONNECTOR | NEEDLELESS CONNECTOR | FPA | ICU MEDICAL, INC. | UNK | S9CD23 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |