FDA Adverse Event
Malfunction
Summary report: N
ICU MEDICAL
MDR report key: 1648711
·
Received February 25, 2010
Report
- Report Number
- 1648711
- Event Type
- Malfunction
- Date Received
- February 25, 2010
- Date of Event
- February 19, 2010
- Report Date
- February 25, 2010
- Manufacturer
- ICU MEDICAL
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OR, US
Narratives
Description of Event or Problem · 1
VERY EARLY DURING A CONTRAST INJECTION FOR CT THE TUBING BROKE. THIS WAS NOT DURING A HIGH PRESSURE RAPID INJECTION BUT OCCURRED VERY EARLY DURING AN ABDOMEN SCAN AT 2ML/SECOND. THE CT TECH SUSPECTS THE TUBING FAILED VERY CLOSE TO ONE OF THE CONNECTORS, BUT THE PRODUCT WAS NOT SAVED. THE PATIENT WAS RESCANNED WITH ANOTHER TUBING SET AND WITHOUT INCIDENT. THE TECH WAS SPLASHED IN THE FACE WITH CONTRAST. I WILL PROVIDE A LOT NUMBER, BUT NO PACKAGING WAS SAVED SO IT'S MOSTLY AN ASSUMPTION THAT IT CAME FROM THE SAME BOX CURRENTLY BEING USED. THE PACKAGE SAYS IT'S FROM SET SOURCE (866-388-3366) BUT THEY SAID THE PRODUCT IS MADE BY ICU MEDICAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICU MEDICAL | TUBING, HIGH PRESSURE EXTENSION | FPA | ICU MEDICAL | Z2666 | 85-836-LA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | NONE KNOWN. |