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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BEMIS MFG. CO. BEMIS 1200CC HIFLOW CANISTER; APPARATUS, SUCTION, VACUUM POWERED
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BEMIS MFG. CO. BEMIS 1200CC HIFLOW CANISTER; APPARATUS, SUCTION, VACUUM POWERED Back to Search Results
Model Number 484410
Device Problem Suction Problem (2170)
Patient Problem No Patient Involvement (2645)
Event Date 10/23/2014
Event Type  malfunction  
Event Description
Complainant stated that during setup for the first pt of the day, a suction canister imploded.There was no pt in the room and no injury reported.Personnel in the room had their backs to the canister and did not see what occurred.
 
Manufacturer Narrative
Reviewed dhr and no discrepancies found.No product is being returned for analysis.No inventory of this lot remains to sample/test.
 
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Brand Name
BEMIS 1200CC HIFLOW CANISTER
Type of Device
APPARATUS, SUCTION, VACUUM POWERED
Manufacturer (Section D)
BEMIS MFG. CO.
sheboygan falls WI 53085
Manufacturer Contact
john cutting
w2940 old city pp
sheboygan falls, WI 53085
9204678927
MDR Report Key4270152
MDR Text Key5007521
Report Number2133713-2014-00012
Device Sequence Number1
Product Code GCX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2017
Device Model Number484410
Device Lot Number20141002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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