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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. STERILIZED CONVENIENCE KIT
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MERIT MEDICAL SYSTEMS, INC. STERILIZED CONVENIENCE KIT Back to Search Results
Catalog Number K09T-11410
Device Problem Air Leak (1008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2015
Event Type  malfunction  
Manufacturer Narrative
No device is expected to be returned for evaluation.Because the unit was not returned, the root cause could not be determined.If the device is returned in the future this investigation will be reopened and a follow up submitted.Since the lot number was not provided, the device history record and complaint database could not be reviewed.
 
Event Description
The user reported that during a cardiac catheterization, air leaked into the syringe passed the syringe plunger tip.The air was seen before it could be injected into the patient.No patient harm or injury was reported.
 
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Brand Name
STERILIZED CONVENIENCE KIT
Type of Device
STERILIZED CONVENIENCE KIT
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
12701 kingston ave
chester VA 23836
Manufacturer (Section G)
MERIT MEDICAL SYSTEMS, INC.
12701 kingston ave
chester VA 23836
Manufacturer Contact
jerry mcphie
1600 west merit parkway
south jordan 84095
8012084491
MDR Report Key5286893
MDR Text Key33232287
Report Number1125782-2015-00036
Device Sequence Number1
Product Code KDD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 11/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberK09T-11410
Was Device Available for Evaluation? No
Date Manufacturer Received11/17/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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