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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
Model Number 00884450298022
Medical Device Problem Code Unsealed Device Packaging (1444)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/19/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.No definitive root cause could be determined however, it 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 or Problem Description
The account alleges that there was a defect in the packaging resulting in incomplete sterilization of the contents.The defect was identified during preparations for a medical procedure.No patient interaction or injury to report.
 
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Brand Name
MERIT CUSTOM KIT
Common Device Name
CUSTOM KIT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan UT 84095
MDR Report Key11269831
Report Number1721504-2021-00004
Device Sequence Number19702239
Product Code OEQ
UDI-Device Identifier00884450298022
UDI-Public00884450298022
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/26/2021
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
Operator of Device No Information
Device Expiration Date07/26/2023
Device Model Number00884450298022
Device Catalogue NumberK04-MZL3508
Device Lot NumberH1873549
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/26/2021
Initial Report FDA Received Date02/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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