ExT™ Stabilized Extension Set with NearPort™ IV Access 390220Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00382903902200), received between Feb 20, 2026 and Sep 29, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935045 ↗
• MalfunctionSep 9, 2026Complete Blockage

  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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695174 ↗
• MalfunctionJul 27, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50026493 ↗
• MalfunctionJul 27, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024654 ↗
• MalfunctionJun 3, 2026Leak/Splash; Improper Flow or Infusion

  IT IS REPORTED THAT EXT EXTENSION SET - BASIC - LEAKAGE LEAKY IV (BRAND BD) SCAN WAS DIAGNOSTIC AND RAN FINE BUT PILLOWS WERE WET AFTER INJECTION. THIS IS AN ONGOING ISSUE WITH THIS PARTICULAR IV BEING USED. THIS HAS BEEN ESCALATED. IMAGING SERVICES PUT IN AN SBAR TO USE ANOTHER IV SYSTEM. WE HAVEN'T HEARD BACK TO SEE IF THIS CAN BE CHANGED. THIS CONTINUES TO OCCUR AND CAUSES THE CONTRAST TO LEAK OVER THE PATIENT. CLEAN UP AND DELAY OF SCAN. AT TIMES THE IV NEEDS TO BE CHANGED. EDUCATION HAS BEEN DONE IN THE ED TO MAKE SURE THE IV IS TIGHTENED. IT SEEMS TO BE A SUPPLY ISSUE BECAUSE IT CONTINUES TO HAPPEN WITH THIS IV SYSTEM. WAS THERE INJURY? REACHED THE INDIVIDUAL BUT DID NOT CAUSE HARM WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? CUSTOMER RESPONDED ON MAY-14: 1: WHEN WE ARE TESTING THE IV EXT SET TO SEE IF WE CAN USE THE IV IS SALINE AND WE ARE HAND PUSHING. AT TIMES IF THE LAB OR SOMEONE ELSE HAS USED THE EXT SET THE CLEAR RUBBER INSIDE IS MOVED IN A WAY THAT WE CAN¿T PUSH SALINE THROUGH THE IV AND WE NEED TO START A NEW IV. 2: WHEN WE TEST THE IV WITH A SALINE PUSH WE CONNECT IT TO OUR POWER INJECTOR IN CT AND PUSH ISOVUE 370 AT THE RATE OF 2ML PER SECOND FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385469 ↗
• MalfunctionJun 3, 2026Leak/Splash; Improper Flow or Infusion

  IT IS REPORTED THAT EXT EXTENSION SET - BASIC - LEAKAGE - FLOW ISSUES - FLUID BLOCKAGE. LEAKY IV (BRAND BD) SCAN WAS DIAGNOSTIC AND RAN FINE BUT PILLOWS WERE WET AFTER INJECTION. THIS IS AN ONGOING ISSUE WITH THIS PARTICULAR IV BEING USED. THIS HAS BEEN ESCALATED. IMAGING SERVICES PUT IN AN SBAR TO USE ANOTHER IV SYSTEM. WE HAVEN'T HEARD BACK TO SEE IF THIS CAN BE CHANGED. THIS CONTINUES TO OCCUR AND CAUSES THE CONTRAST TO LEAK OVER THE PATIENT. CLEAN UP AND DELAY OF SCAN. AT TIMES THE IV NEEDS TO BE CHANGED. EDUCATION HAS BEEN DONE IN THE ED TO MAKE SURE THE IV IS TIGHTENED. IT SEEMS TO BE A SUPPLY ISSUE BECAUSE IT CONTINUES TO HAPPEN WITH THIS IV SYSTEM. WAS THERE INJURY? REACHED THE INDIVIDUAL BUT DID NOT CAUSE HARM WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? CUSTOMER RESPONDED ON (B)(6): 1: WHEN WE ARE TESTING THE IV EXT SET TO SEE IF WE CAN USE THE IV IS SALINE AND WE ARE HAND PUSHING. AT TIMES IF THE LAB OR SOMEONE ELSE HAS USED THE EXT SET THE CLEAR RUBBER INSIDE IS MOVED IN A WAY THAT WE CAN¿T PUSH SALINE THROUGH THE IV AND WE NEED TO START A NEW IV. 2: WHEN WE TEST THE IV WITH A SALINE PUSH, WE CONNECT IT TO OUR POWER INJECTOR IN CT AND PUSH ISOVUE 370 A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385468 ↗
• MalfunctionJun 3, 2026Leak/Splash; Improper Flow or Infusion

  IT IS REPORTED THAT EXT EXTENSION SET - BASIC - LEAKAGE - FLOW ISSUES - FLUID BLOCKAGE. LEAKY IV (BRAND BD) SCAN WAS DIAGNOSTIC AND RAN FINE BUT PILLOWS WERE WET AFTER INJECTION. THIS IS AN ONGOING ISSUE WITH THIS PARTICULAR IV BEING USED. THIS HAS BEEN ESCALATED. IMAGING SERVICES PUT IN AN SBAR TO USE ANOTHER IV SYSTEM. WE HAVEN'T HEARD BACK TO SEE IF THIS CAN BE CHANGED. THIS CONTINUES TO OCCUR AND CAUSES THE CONTRAST TO LEAK OVER THE PATIENT. CLEAN UP AND DELAY OF SCAN. AT TIMES THE IV NEEDS TO BE CHANGED. EDUCATION HAS BEEN DONE IN THE ED TO MAKE SURE THE IV IS TIGHTENED. IT SEEMS TO BE A SUPPLY ISSUE BECAUSE IT CONTINUES TO HAPPEN WITH THIS IV SYSTEM. WAS THERE INJURY? REACHED THE INDIVIDUAL BUT DID NOT CAUSE HARM WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? CUSTOMER RESPONDED ON (B)(6): 1: WHEN WE ARE TESTING THE IV EXT SET TO SEE IF WE CAN USE THE IV IS SALINE AND WE ARE HAND PUSHING. AT TIMES IF THE LAB OR SOMEONE ELSE HAS USED THE EXT SET THE CLEAR RUBBER INSIDE IS MOVED IN A WAY THAT WE CAN¿T PUSH SALINE THROUGH THE IV AND WE NEED TO START A NEW IV. 2: WHEN WE TEST THE IV WITH A SALINE PUSH WE CONNECT IT TO OUR POWER INJECTOR IN CT AND PUSH ISOVUE 370 AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25385462 ↗
• MalfunctionMay 27, 2026Infusion or Flow Problem

  EVENT DETAILS: ¿STAFF ARE REPORTING SOME IV EXTENSIONS ARE NOT FLUSHING FROM LOT REKX1857-LOT REKX2396. REF# FOR THE ITEM IS 390220, NOT FLUSHING ON THE PIVO ACCESS PORT¿. CUSTOMER RESPONSE ON 12-MAY-2026. CAN YOU PLEASE PROVIDE THE DATE OF EVENT? (B)(6) 2026. DESCRIPTION OF ANY PATIENT HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME ASSOCIATED WITH THE EVENT: ERROR OCCURRED BUT DID NOT REACH THE INDIVIDUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25305881 ↗
• MalfunctionFeb 20, 2026Connection Problem

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406100 ↗