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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC LIMITED EASI-V SECUREMENT DEVICE; INTRAVASCULAR CATHETER SECUREMENT
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CONVATEC LIMITED EASI-V SECUREMENT DEVICE; INTRAVASCULAR CATHETER SECUREMENT Back to Search Results
Model Number 417103
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2015
Event Type  malfunction  
Event Description
It was reported the securement device "doesn't have satisfactory adhesiveness" after two to three days of use.No patient consequences were reported as a result of this event.
 
Manufacturer Narrative
Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.Additional patient/event details have been requested.Should additional information become available, a follow-up report will be submitted.Reported to the fda on (b)(4) 2015.
 
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Brand Name
EASI-V SECUREMENT DEVICE
Type of Device
INTRAVASCULAR CATHETER SECUREMENT
Manufacturer (Section D)
CONVATEC LIMITED
first avenue
deeside industrial park
deeside, flintshire CH5 2NU
UK  CH5 2NU
Manufacturer Contact
matthew walenciak, int. assoc. di
211 american avenue
greensboro, NC 27409
9083779293
MDR Report Key4726820
MDR Text Key5739895
Report Number1000317571-2015-00029
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 03/16/2015
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 Date11/01/2015
Device Model Number417103
Device Lot Number3L02095
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/16/2015
Initial Date FDA Received04/23/2015
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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