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