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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BEMIS MFG. CO. BEMIS 1200CC HIFLOW SUCTION CANISTER; BOTTLE, COLLECTION, VACUUM
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BEMIS MFG. CO. BEMIS 1200CC HIFLOW SUCTION CANISTER; BOTTLE, COLLECTION, VACUUM Back to Search Results
Model Number 480410
Device Problem Suction Problem (2170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2014
Event Type  malfunction  
Event Description
A suction unit that had been out of service for an indeterminate time was brought out and tested at full vacuum and the canister cover imploded.No injury to the tech doing the testing.
 
Manufacturer Narrative
Returned product was photographed and subject to ftir analysis.Ftir indicated a high degree of oxidation consistent with uv embrittlement.Customer stated product was found in storage where it had remained for an indeterminate time period.Probable cause of failure: uv embrittlement due to excessive uv exposure.Since (b)(4) 2007 this product bears a three-year expiration date.Since (b)(4) 2011 the plastic used in the canister cover has a uv inhibitor and anti-oxidant package.
 
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Brand Name
BEMIS 1200CC HIFLOW SUCTION CANISTER
Type of Device
BOTTLE, COLLECTION, VACUUM
Manufacturer (Section D)
BEMIS MFG. CO.
sheboygan falls WI 53085
Manufacturer Contact
john cutting
e2940 old cty pp
sheboygan falls, WI 53085
9204678927
MDR Report Key3883107
MDR Text Key4426262
Report Number2133713-2014-00005
Device Sequence Number1
Product Code KDQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number480410
Device Lot Number20060313
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/18/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/11/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2006
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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