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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT CUSTOM KIT INTRAVENOUS EXTENSION TUBING SET

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MERIT MEDICAL SYSTEMS, INC. MERIT CUSTOM KIT INTRAVENOUS EXTENSION TUBING SET Back to Search Results
Catalog Number K04-MZL6505
Device Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect device was 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 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 NameMERIT CUSTOM KIT
Type of DeviceINTRAVENOUS EXTENSION TUBING SET
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
1600 merit parkway
south jordan, ut
Manufacturer (Section G)
MERIT MEDICAL SYSTEMS, INC.
1600 merit parkway
south jordan, ut
Manufacturer Contact
david lockridge
1600 merit parkway
south jordan, ut 
2084551
MDR Report Key9712684
MDR Text Key186549544
Report Number1721504-2020-00008
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 12/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberK04-MZL6505
Device Lot NumberH1583957
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2019
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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