Extension Set 470172Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04046964580215), received between Nov 21, 2016 and May 9, 2023 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION; LEAKAGE OF BLOOD OCCURRED. WHILE REMOVING THE VACUTAINER FROM THE EXTENSION TUBING THE VACUTAINER CRACKED AROUND THE LEUR LOCK ATTACHMENT POINT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899141 ↗
• MalfunctionMay 5, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: WHILE ATTEMPTING TO REMOVE THE VACUTAINER FROM THE EXTENSION SET THE TIP OF THE VACUTAINER BROKE OFF AND IS STUCK IN THE LEUR LOCK. NO INJURY REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16875079 ↗
• MalfunctionMay 5, 2023Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: RN WAS DISCONNECTING IV TUBING FORM IV PIGTAIL: PLASTIC END BROKE OFF IN IV PIGTAIL. THIS LEFT THE SYSTEM WITH AN OPEN VACUUM AND BLOOD POURED OUT FROM THE IV. RN HELD PRESSURE OVER IV SITE AND REPLACED PIGTAIL TO MAINTAIN IV ACCESS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875061 ↗
• MalfunctionMay 1, 2023Break; Leak/Splash; Break; Leak/Splash

  AS REPORTED BY THE USER FACILITY: RN WAS DISCONNECTING IV TUBING FROM IV PIGTAIL; PLASTIC END BROKE OFF IN IV PIGTAIL. THIS LEFT THE SYSTEM WITH AN OPEN VACUUM AND BLOOD POURED OUT FROM THE IV. RN HELD PRESSURE OVER IV SITE AND REPLACED PIGTAIL TO MAINTAIN IV ACCESS. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16847838 ↗
• MalfunctionJul 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: END USER REPORTS: "IV TUBING WAS STUCK CONNECTED TO EXTENSION SET. RN PULLED ON TUBING TO REMOVE. PLASTIC PIECE BROKE OFF OF IV TUBING IN EXTENSION SET CAUSING A VACUUM WHERE THE PATIENT'S BLOOD BEGAN POURING OUT OF THE EXTENSION SET." NOTE: EXTENSION SET WAS ATTACHED TO NON-B. BRAUN PUMP INFUSION SET. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172290 ↗
• MalfunctionNov 5, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 3: CUSTOMER REPORTS SEVERAL INCIDENCES OF PRIMARY SET BREAKING OFF IN THE CARESITE ON TRYING TO REMOVE THE PRIMARY SET. WHEN THE NURSE WENT INTO THE PATIENT'S ROOM TO DISCONNECT HER FROM HER EVENING DOSE OF ANTIBIOTICS. UPON DISCONNECTING THE PRIMARY TUBING FROM THE PATIENT THE END PIECE BROKE OFF INSIDE THE CONNECTION TUBING THAT WAS CONNECTED TO THE PATIENT. THE BROKEN PIECE INSIDE KEPT THE FLOW OPEN SO BLOOD WAS COMING BACK OUT OF THE IV LINE. THIS RN HAD TO DISCONNECT THE EXTENSION TUBING FROM THE CANNULA/ CATHETER AND CONNECT A NEW ONE. NO INJURY REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8037523 ↗
• MalfunctionNov 5, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 3: CUSTOMER REPORTS SEVERAL INCIDENCES OF PRIMARY SET BREAKING OFF IN THE CARESITE ON TRYING TO REMOVE THE PRIMARY SET. WHEN THE NURSE WENT INTO THE PATIENT'S ROOM TO DISCONNECT HER FROM HER EVENING DOSE OF ANTIBIOTICS. UPON DISCONNECTING THE PRIMARY TUBING FROM THE PATIENT THE END PIECE BROKE OFF INSIDE THE CONNECTION TUBING THAT WAS CONNECTED TO THE PATIENT. THE BROKEN PIECE INSIDE KEPT THE FLOW OPEN SO BLOOD WAS COMING BACK OUT OF THE IV LINE. THIS RN HAD TO DISCONNECT THE EXTENSION TUBING FROM THE CANNULA/ CATHETER AND CONNECT A NEW ONE. NO INJURY REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8037424 ↗
• MalfunctionNov 5, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER REPORTS SEVERAL INCIDENCES OF PRIMARY SET BREAKING OFF IN THE CARESITE ON TRYING TO REMOVE THE PRIMARY SET. WHEN THE NURSE WENT INTO THE PATIENT'S ROOM TO DISCONNECT HER FROM HER EVENING DOSE OF ANTIBIOTICS. UPON DISCONNECTING THE PRIMARY TUBING FROM THE PATIENT THE END PIECE BROKE OFF INSIDE THE CONNECTION TUBING THAT WAS CONNECTED TO THE PATIENT. THE BROKEN PIECE INSIDE KEPT THE FLOW OPEN SO BLOOD WAS COMING BACK OUT OF THE IV LINE. THIS RN HAD TO DISCONNECT THE EXTENSION TUBING FROM THE CANNULA/ CATHETER AND CONNECT A NEW ONE. NO INJURY REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8037423 ↗
• MalfunctionNov 21, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY USER FACILITY: EVENT 5. REPORTS WITNESSED PATIENT IN DIALYSIS RECEIVING INFUSION/TRANSFUSION BLOOD WAS LEAKING OUT OF THE PORT SITE SIDES IT APPEARED. NOTED TO HAVE HAPPENED APPROXIMATELY 5 TIMES. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6118349 ↗
• MalfunctionNov 21, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY USER FACILITY: EVENT 4. REPORTS WITNESSED PATIENT IN DIALYSIS RECEIVING INFUSION/TRANSFUSION BLOOD WAS LEAKING OUT OF THE PORT SITE SIDES IT APPEARED. NOTED TO HAVE HAPPENED APPROXIMATELY 5 TIMES. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6118333 ↗
• MalfunctionNov 21, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY USER FACILITY: EVENT 3. REPORTS WITNESSED PATIENT IN DIALYSIS RECEIVING INFUSION/TRANSFUSION BLOOD WAS LEAKING OUT OF THE PORT SITE SIDES IT APPEARED. NOTED TO HAVE HAPPENED APPROXIMATELY 5 TIMES. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6118326 ↗
• MalfunctionNov 21, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY USER FACILITY: EVENT 2: REPORTS WITNESSED PATIENT IN DIALYSIS RECEIVING INFUSION/TRANSFUSION BLOOD WAS LEAKING OUT OF THE PORT SITE SIDES IT APPEARED. NOTED TO HAVE HAPPENED APPROXIMATELY 5 TIMES. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6118321 ↗
• MalfunctionNov 21, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY USER FACILITY: EVENT 1: REPORTS WITNESSED PATIENT IN DIALYSIS RECEIVING INFUSION/TRANSFUSION BLOOD WAS LEAKING OUT OF THE PORT SITE SIDES IT APPEARED. NOTED TO HAVE HAPPENED APPROXIMATELY 5 TIMES. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6118319 ↗