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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT CUSTOM KIT
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MERIT MEDICAL SYSTEMS, INC. MERIT CUSTOM KIT Back to Search Results
Catalog Number K09-MST2144A
Device Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/25/2015
Event Type  malfunction  
Event Description
The user reported that air entered the syringe through the manifold rotator during aspiration.The device was replaced that the procedure was completed.No harm or injury to the patient was reported.
 
Manufacturer Narrative
Is this a single-use device that was reprocessed and reused on a patient? this information was not provided by the user.Device evaluation.One device returned for evaluation.The investigation is in-process.A follow up report will be submitted when the evaluation has been completed.
 
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Brand Name
MERIT CUSTOM KIT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
south jordan UT
Manufacturer (Section G)
.
Manufacturer Contact
jerry mcphie
1600 west merit pkwy.
south jordan, UT 84095
8012084749
MDR Report Key4741797
MDR Text Key15959467
Report Number1721504-2015-00083
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K913682
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 04/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2017
Device Catalogue NumberK09-MST2144A
Device Lot NumberH725390
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/14/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received04/07/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2014
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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