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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC LIMITED EASI-V SECUREMENT DEVICE; DEVICE, INTRAVASCULAR CATHETER SECUREMENT
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CONVATEC LIMITED EASI-V SECUREMENT DEVICE; DEVICE, INTRAVASCULAR CATHETER SECUREMENT Back to Search Results
Model Number 417109
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2015
Event Type  malfunction  
Event Description
It was reported the easi-v securement device no longer adhered to the skin after two days of use.The securement device was removed and replaced.No patient consequences were reported as a result of this event.
 
Manufacturer Narrative
Based on the available info, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.Should additional info become available, a f/u report will be submitted.(b)(4).
 
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Brand Name
EASI-V SECUREMENT DEVICE
Type of Device
DEVICE, INTRAVASCULAR CATHETER SECUREMENT
Manufacturer (Section D)
CONVATEC LIMITED
unit 20, first avenue
deeside industrial park
deeside, flintshire CH5 2NU
UK  CH5 2NU
Manufacturer Contact
matthew walenciak, dir
211 american ave
greensboro, NC 27409
9083779293
MDR Report Key4736371
MDR Text Key5584170
Report Number1000317571-2015-00041
Device Sequence Number1
Product Code KMK
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/01/2015
Device Model Number417109
Device Lot Number3K01120
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/08/2015
Initial Date FDA Received04/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
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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