ExT Extension Set
Received Jul 29, 2026 · Event occurred Jul 8, 2026
Report 1710034-2026-00855 · MDR key 50070613
Device
Generic name
Set, Administration, Intravascular
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.Catalog number
390220
Lot number
Unknown
Product problems
- Obstruction of Flow
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that BD ExT Extension Set ¿ Basic fluid blockage.Situation:This patient's IV wasn't connected tight enough and came disconnected during CT contrast administration. The IV extension set tubing with stabilizer came undone from the actual catheter and caused significant delay in care, made a mess all over the patient and made it so the bolus was split into 3 different injections with me trying to fix her IV in between each one. Because I had to undress this IV it also caused an increased risk for infection. CT is the only department to catch the problem because we inject IV's (we can only use the main port) much faster than anyone else with a lot more pressure behind it. The other issue is that the main port is defective a lot of the time and won't draw or flush. But the pigtail will. So, the extension set must be replaced completely.Background:Event Date: (b)(6) 2026.Was there Injury? No.
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined. The device history records could not be evaluated as the lot number is unknown. Complaints received for this product and condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business regularly reviews the collected data for identification of emerging trends.