MAUDE Adverse Event Report: ARGON TRIPLE TRANSDUCER KIT

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.

• Brand Name: TRIPLE TRANSDUCER KIT
• Type of Device: TRIPLE TRANSDUCER KIT
• Manufacturer (Section D): ARGON; plano TX 75024
• MDR Report Key: 6072191
• MDR Text Key: 59065991
• Report Number: MW5065751
• Device Sequence Number: 1
• Product Code: DXN
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2021
• Device Lot Number: 11154951
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1