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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS DIAGNOSITC PERIPHERAL CATHETER
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MERIT MEDICAL SYSTEMS, INC. IMPRESS DIAGNOSITC PERIPHERAL CATHETER Back to Search Results
Catalog Number 565352HK0-8
Device Problem Torn Material (3024)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/21/2015
Event Type  Injury  
Event Description
The user reported that the tip of the catheter separated from the shaft.The user has not provided clinical info for this event.Two lot numbers were provided for this complaint.No info was provided indicating which lot is related to this complaint.
 
Manufacturer Narrative
Add'l lot info: lot no: e758835, exp date: 02/28/2018.Add'l lot info: device manufacture date: 03/2015.The device has not been returned for eval.A f/u report will be sent when the eval has been completed.
 
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Brand Name
IMPRESS DIAGNOSITC PERIPHERAL CATHETER
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
south jordan UT
Manufacturer Contact
jerry mcphie
1600 w merit pkwy
s jordan, UT 84095
8012084491
MDR Report Key4774416
MDR Text Key5782391
Report Number1628221-2015-00005
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K053171
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2017
Device Catalogue Number565352HK0-8
Device Lot NumberE680436
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received04/21/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
AMPLATZ WIRE
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