FDA Adverse Event
Malfunction
Summary report: N
ALARIS ADMINISTRATION SET
MDR report key: 1339567
·
Received January 7, 2009
Report
- Report Number
- 9616066-2009-00007
- Event Type
- Malfunction
- Date Received
- January 7, 2009
- Report Date
- January 5, 2009
- Manufacturer
- CARDINAL HEALTH ALARIS PRODUCTS
- Product Code
- FPA
- PMA / PMN Number
- K022209
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER'S REPORT DATE: 01/07/2009. PATIENT'S INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED.
Description of Event or Problem · 1
EVENT DATE UNK. NURSE REPORTED BLOOD TUBING CRACKING AND THEN LEAKING AT THE BASE OF THE DRIP CHAMBER. PRODUCT NOT RECEIVED AS OF THE TIME OF THIS REPORT. IF PRODUCT IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT WHEN INVESTIGATION COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS ADMINISTRATION SET | FPA | CARDINAL HEALTH ALARIS PRODUCTS | 28080E | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |