FDA Adverse Event
Malfunction
Summary report: N
BEMIS 2000CC HI-FLOW SUCTION CANISTER
MDR report key: 3184864
·
Received June 12, 2013
Report
- Report Number
- 2133713-2013-00009
- Event Type
- Malfunction
- Date Received
- June 12, 2013
- Date of Event
- May 31, 2013
- Report Date
- June 12, 2013
- Manufacturer
- BEMIS MFG. CO.
- Product Code
- GCX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SERIAL NUMBER (B)(4) CORRESPONDS TO LOTS 20130408, 20130409, 20130410 AND 20130429.
Description of Event or Problem · 1
COMPLAINANT STATED SUCTION CANISTER IMPLODED. THERE WERE NO PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267685 | BEMIS 2000CC HI-FLOW SUCTION CANISTER | APPARATUS, VACUUM, SUCTON POWERED | GCX | BEMIS MFG. CO. | 494410 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |