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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-MST2293
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2014
Event Type  malfunction  
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.
 
Manufacturer Narrative
One unused device was returned for eval.A packaging test was performed and a breach was identified in the packaging.The complaint was confirmed.No root cause was determined.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaint 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 Key4307156
MDR Text Key5193142
Report Number1721504-2014-00277
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 Other,Foreign,Company Representative,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 11/05/2014
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 Other
Device Expiration Date08/31/2017
Device Catalogue NumberK09-MST2293
Device Lot NumberH682978
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/12/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/05/2014
Initial Date FDA Received11/25/2014
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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