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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BEEVERS MANUFACTURING AND SUPPLY, INC CANNULAIDE

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BEEVERS MANUFACTURING AND SUPPLY, INC CANNULAIDE Back to Search Results
Device Problem Inadequate or Insufficient Training (1643)
Patient Problem Unspecified Infection (1930)
Event Date 03/24/2009
Event Type  Injury  
Event Description
On (b)(6) 2009 beevers manufacturing and supply inc., (bms) was notified of a complaint that asserts that a cannulaide device caused a breakout of staph infection.Salter labs acquired bms on (b)(6) 2014 and found no record that bms followed-up with the complaint.Multiple (six) additional attempts of contact were made in 2014 without response.The bms distributor advised salter labs that additional training was provided to the end-user medical facility in 2009 and there have been no reports of similar incidents since then.This is the initial and final report.
 
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Brand Name
CANNULAIDE
Type of Device
CANNULAIDE
Manufacturer (Section D)
BEEVERS MANUFACTURING AND SUPPLY, INC
850 sw booth bend road
mcminnville OR 97128
Manufacturer Contact
aurelia brownridge
2365 camino vida roble
carlsbad, CA 92011
7607957102
MDR Report Key4179974
MDR Text Key5097411
Report Number3023468-2014-00004
Device Sequence Number1
Product Code NHJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2009
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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