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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MERIT CUSTOM KITS; INTRAVENOUS EXTENSION TUBING SET KIT
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MERIT MEDICAL SYSTEMS INC. MERIT CUSTOM KITS; INTRAVENOUS EXTENSION TUBING SET KIT Back to Search Results
Catalog Number K08-MP5164
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 08/12/2020
Event Type  malfunction  
Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
Account alleges that there is a foreign object within the fluid path.
 
Manufacturer Narrative
The suspect device has been returned for evaluation.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.Corrective actions are in process.
 
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Brand Name
MERIT CUSTOM KITS
Type of Device
INTRAVENOUS EXTENSION TUBING SET KIT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan, ut
MDR Report Key10483306
MDR Text Key205328224
Report Number1721504-2020-00065
Device Sequence Number1
Product Code OJA
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/30/2023
Device Catalogue NumberK08-MP5164
Device Lot NumberH1858980
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2020
Date Manufacturer Received09/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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