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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 OSC-5F-7/A
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2015
Event Type  malfunction  
Event Description
The user reported that during a paracentesis procedure, the needle inside the catheter could not be removed and the device had to be replaced.The procedure was completed with a new device.
 
Manufacturer Narrative
The device has not returned for evaluation.A follow up report will be sent when the evaluation 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 mcpie
1600 west merit pkwy.
south jordan, UT 84095
8012084491
MDR Report Key4567587
MDR Text Key18919123
Report Number1721504-2015-00044
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 Health Professional,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 02/04/2015
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 Date10/31/2017
Device Catalogue NumberOSC-5F-7/A
Device Lot NumberH706069
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/04/2015
Initial Date FDA Received02/25/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2014
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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