FDA Adverse Event
Malfunction
Summary report: N
BEMIS 800CC HYDROPHOBIC SUCTION CANISTER
MDR report key: 1003717
·
Received February 19, 2008
Report
- Report Number
- 2133713-2008-00001
- Event Type
- Malfunction
- Date Received
- February 19, 2008
- Date of Event
- January 21, 2008
- Report Date
- February 18, 2008
- Manufacturer
- BEMIS MANUFACTURING
- Product Code
- KDQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SAMPLES FROM THE SAME BATCH THAT HAD THE ALLEGED FAILURE WERE RETURNED BY REP FOR TESTING. FAILURE COULD NOT BE DUPLICATED.
Description of Event or Problem · 1
SALES REP WAS DEMONSTRATING 800CC SUCTION CANISTER WITH HYDROPHOBIC SHUTOFF. DURING DEMONSTRATION, THERE WAS A FLUID BACKUP. THERE WERE NO PATIENT CONSEQUENCES, AND NO EXPOSURE TO FLUID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BEMIS 800CC HYDROPHOBIC SUCTION CANISTER | BOTTLE, COLLECTION, VACUUM | KDQ | BEMIS MANUFACTURING | 424410 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |