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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. HIGH PRESSURE TUBING KIT

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MERIT MEDICAL SYSTEMS, INC. HIGH PRESSURE TUBING KIT Back to Search Results
Catalog Number K04-MZL6505
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 04/18/2019
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 review of the device history record was performed and no exception documents were found. A review of the complaint database was performed and no similar complaints for this lot number were found.
 
Manufacturer Narrative
The suspect device has been returned for evaluation. A follow up will be submitted when the evaluation is complete.
 
Event Description
The distributor reported a foreign object inside the fluid path of the rotator. This was identified during their initial inspection of received product. The device was not sent to a user facility.
 
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Brand NameHIGH PRESSURE TUBING KIT
Type of DeviceHIGH PRESSURE TUBING KIT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
1600 w merit parkway
south jordan 84095
Manufacturer (Section G)
MERIT MEDICAL SYSTEMS, INC.
1600 w merit parkway
south jordan 84095
Manufacturer Contact
katie swenson, cqe, cba, cqpa
1600 w merit parkway
south jordan 84095
8012081600
MDR Report Key8923056
MDR Text Key157719366
Report Number1721504-2019-00067
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,Followup
Report Date 07/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberK04-MZL6505
Device Lot NumberH1512907
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2019
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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