FDA Adverse Event
Summary report: N
BLOOD ADMINISTRATION SET
MDR report key: 3070490
·
Received April 16, 2013
Report
- Report Number
- MW5029845
- Date Received
- April 16, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 16, 2013
- Manufacturer
- B BRAUN
- Product Code
- BRZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
EVENT TUBING - SPIKED BLOOD Y-SET TO FLUID, WAS NOT ABLE TO GET FLUID TO FLOW THROUGH THE SYSTEM. EVENT TUBING - PRACTITIONER SQUEEZED THE BLOOD Y-SET TO DELIVER FLUID TO THE PT; THE BALL GOT CAUGHT UP IN THE TUBING AND DID NOT ALLOW THE FLUID TO MOVE THROUGHOUT THE TUBING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164165 | BLOOD ADMINISTRATION SET | BLOOD ADMINISTRATION SET | BRZ | B BRAUN | 375154 | 0061283058 | |
| 164166 | BLOOD ADMINISTRATION SET | BLOOD ADMINISTRATION SET | BRZ | B. BRAUN | 375154 | 0061283058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |