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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-MZTS1201A
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Date 02/16/2017
Event Type  malfunction  
Manufacturer Narrative
The suspect device was returned for evaluation.The device was visually inspected.The complaint is confirmed.The root cause is attributed to the manufacturing process.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.
 
Event Description
The distributor alleged 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 Name
MERIT CUSTOM KIT
Type of Device
CUSTOM KIT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
1600 merit parkway
south jordan 84095
Manufacturer (Section G)
MERIT MEDICAL SYSTEMS, INC.
1600 merit parkway
south jordan 84095
Manufacturer Contact
casey hughes, ms, cqe, csqp
1600 merit parkway
south jordan 84095
MDR Report Key6721931
MDR Text Key80315069
Report Number1721504-2017-00151
Device Sequence Number1
Product Code DQO
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 Other
Type of Report Initial
Report Date 06/11/2017
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 Date11/30/2019
Device Catalogue NumberK12-MZTS1201A
Device Lot NumberH1049261
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2017
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/13/2017
Initial Date FDA Received07/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2016
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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