FDA Adverse Event
Injury
Summary report: N
RADIAL ARTERY PRESSURE MONITORING SET
MDR report key: 2142920
·
Received June 22, 2011
Report
- Report Number
- 1820334-2011-00322
- Event Type
- Injury
- Date Received
- June 22, 2011
- Date of Event
- May 16, 2011
- Report Date
- May 26, 2011
- Manufacturer
- COOK INC
- Product Code
- DQY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EXPIRATION - UNK AS LOT IS UNK. (B)(4). EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
BLOOD WAS NOTED TO BE SOAKING THROUGH THE DRESSING AND ARTERIAL WAVE FORM SUDDENLY WENT FLAT. UPON REMOVAL, IT WAS NOTED THAT FLUID WAS DRIPPING THROUGH THE AREA WHERE THE CATHETER JOINS WITH THE FLANGE. IT WAS A CLOSE CALL BECAUSE THE ARTERIAL LINE WAS LEAKING PT'S BLOOD. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIAL ARTERY PRESSURE MONITORING SET | DQY CATHETER, PERCUTANEOUS | DQY | COOK INC | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |