MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. ExT Extension Set; Set, Administration, Intravascular

Catalog Number	390220
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd ext extension set - basic was occluded.This was a code stroke patient from the ed.While doing his contrast injection for cta, the iv failed part way through the injection.It was the bd ext stabilized extension set with nearport iv access.Iv was placed in the emergency room.I hand flushed the iv and it worked great, we power flushed the iv and it worked great, then about 15 ml into the contrast power injection it failed.This caused a significant delay in patient care.The nurse wasn't aware that it was the extension set that failed, so she assumed it was the entire iv that failed.She ended up pulling the iv and placing another iv.That's another issue.This is the first time i've ever seen this fail part way through the injection, but these fail quite often.Was there injury? no.
Additional Manufacturer Narrative
A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

• Brand Name: ExT Extension Set
• Common Device Name: Set, Administration, Intravascular
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50695174
• Report Number: 1710034-2026-00989
• Device Sequence Number: 15856747
• Product Code: FPA
• UDI-Device Identifier: 00382903902200
• UDI-Public: (01)00382903902200
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K200439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 390220
• Device Lot Number: Unknown
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown