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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT CUSTOM KIT; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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MERIT MEDICAL SYSTEMS, INC. MERIT CUSTOM KIT; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number K12-05299
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/10/2014
Event Type  malfunction  
Event Description
The user reported that the valve in the hub of the catheter dislodged and occluded the catheter.The device was removed and the procedure was completed with a replacement catheter.No harm or injury to the pt was reported.
 
Manufacturer Narrative
Device eval: one device was returned for eval.The eval is in process.A f/u report will be submitted when the eval has been completed.
 
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Brand Name
MERIT CUSTOM KIT
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
richmond VA
Manufacturer Contact
jerry mcphie
1600 west merit pkwy.
south jordan, UT 84095
8012084491
MDR Report Key4322013
MDR Text Key5249478
Report Number1721504-2014-00280
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 11/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2016
Device Catalogue NumberK12-05299
Device Lot NumberH682668
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/12/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received11/11/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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