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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 K12-MZRS1201A
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2014
Event Type  malfunction  
Event Description
The distributor reported that a foreign object was identified in the fluid path of the transducer included in the kit during their initial inspection of received product.The device was not sent to a user facility.
 
Manufacturer Narrative
One unused suspect device was returned for eval.The device was examined visually.Particulate larger than the acceptance criteria was found.The complaint was confirmed for this device.No root cause was determined.The device history record was reviewed and no related exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.
 
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Brand Name
MERIT CUSTOM KIT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
south jordan UT
Manufacturer Contact
jerry mcphie
1600 west merit pkwy.
south jordan, UT 84095
8012084491
MDR Report Key4360661
MDR Text Key5117257
Report Number1721504-2014-00288
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K920977
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2017
Device Catalogue NumberK12-MZRS1201A
Device Lot NumberH662587
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/16/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received12/02/2014
Was Device Evaluated by Manufacturer? Yes
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 Initial
Patient Sequence Number1
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