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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 K04-MZL6501
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 01/23/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect device has been returned for evaluation. The device was examined visually. The complaint is confirmed. The root cause is attributed to the manufacturing process. A search of the complaint database was performed and no similar complaints for this lot number were found. The device history record was reviewed, and no exception documents were found.
 
Event Description
The distributor reported a defect in the packaging. This was identified during their initial inspection of received product. The device was not sent to a user facility.
 
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Brand NameMERIT CUSTOM KIT
Type of DeviceCUSTOM KIT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan, UT 84095
Manufacturer (Section G)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan, UT 84095
Manufacturer Contact
katie swenson cqe,cba,cqpa.
1600 merit parkway
south jordan, UT 84095
8012531600
MDR Report Key8578792
MDR Text Key144271093
Report Number1721504-2019-00030
Device Sequence Number1
Product Code OJA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 03/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Catalogue NumberK04-MZL6501
Device Lot NumberH1434618
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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