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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. IMPRESS DIAGNOSTIC PERIPHERAL CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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MERIT MEDICAL SYSTEMS INC. IMPRESS DIAGNOSTIC PERIPHERAL CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number 512538HH1
Device Problem Torn Material (3024)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/15/2015
Event Type  malfunction  
Event Description
A catheter was returned by the customer without any clinical details or identification.The tip of the catheter was missing from the device.The date of the event and referenced catalog number are estimations.
 
Manufacturer Narrative
Device evaluation: one device was returned for evaluation.The tip of the catheter was missing.The body of the catheter showed evidence of proper manufacturing.No root cause for the damage could be determined.Since the lot number was not provided, the device history record and complaint database could not be reviewed.
 
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Brand Name
IMPRESS DIAGNOSTIC PERIPHERAL CATHETER
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
south jordan UT
Manufacturer Contact
jerry mcphie
1600 west merit parkway
south jordan, UT 84095
8012084491
MDR Report Key4844602
MDR Text Key5946778
Report Number3010665433-2015-00006
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K053171
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number512538HH1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/07/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received05/15/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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