MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMALL BORE STOPCOCKS; STOPCOCK, I.V. SET

Model Number 109955

Device Problem Failure to Prime (1492)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2021

Event Type  malfunction  

Event Description

Trifuse iv extension set unable to be primed at sterile tubing change on a cvad.Necessitated another rn to bring another extension to the room so sterility did not have to be breached.

• Brand Name: SMALL BORE STOPCOCKS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 12922898
• MDR Text Key: 281660464
• Report Number: 12922898
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 109955
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2021
• Date Report to Manufacturer: 12/03/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1