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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON TRIPLE TRANSDUCER KIT

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ARGON TRIPLE TRANSDUCER KIT Back to Search Results
Lot Number 11154951
Device Problems Break (1069); Connection Problem (2900); Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)
Patient Problem No Information (3190)
Event Date 10/27/2016
Event Type  malfunction  
Event Description
Specific lots of argon triple transducer sets were inappropriately glue sealed at all stopcocks when put together by the manufacturer. If you try to disconnect connection and it's glue sealed, the connection will break causing problems. When someone tried to make a change in the arterial line it did snap. The connection was from one of the glue sealed kits.
 
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Brand NameTRIPLE TRANSDUCER KIT
Type of DeviceTRIPLE TRANSDUCER KIT
Manufacturer (Section D)
ARGON
plano TX 75024
MDR Report Key6072191
MDR Text Key59065991
Report NumberMW5065751
Device Sequence Number1
Product Code DXN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/31/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/08/2021
Device Lot Number11154951
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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