MAUDE Adverse Event Report: SMITH'S MEDICAL ASD INC.; STOPCOCK, I.V. SET

Catalog Number MX252

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2021

Event Type  malfunction  

Event Description

Patient came for a return visit to redo imaging for mri due to contrast not showing up on imaging during previous encounter.Iv started by rn with excellent blood return and flushed easily.Three way stopcock attached for contrast administration.Upon administration of contrast none was viewed on images by radiologist.Patient pulled out of device and site assessed.Connection found loose between stopcock and iv catheter with serosanguineous drainage noted.Iv removed and secondary iv started in other extremity using the same equipment.Rn secured device with standard tegaderm as well as a chevron style application of tape around the connection and extra tape over the hub.Second administration of contrast successful for imaging.Of note, patient returned today to have images repeated due to the contrast not showing up.Reported from mri staff that a similar event occurred her first scan.Connection came loose, causing loss of medication and loss of iv access.

• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITH'S MEDICAL ASD INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 13190912
• MDR Text Key: 283414553
• Report Number: 13190912
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2021

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 Catalogue Number: MX252
• Device Lot Number: 4161930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Female