Extension Set 471954Recalls & reported problems
B. Braun Medical Inc. · Small bore extension set with distal T-port and SPIN-LOCK® Connector. · Class 2
All models of Extension Set (41)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04022495770103), received between Nov 29, 2016 and Oct 2, 2024 — classified as 1 injury, 19 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak7
- Loose or Intermittent Connection6
- Contamination /Decontamination Problem2
- Device Operates Differently Than Expected2
- Leak/Splash2
- Detachment of Device or Device Component1
- Free or Unrestricted Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Blood Loss6
- No Consequences Or Impact To Patient3
- Hemorrhage/Blood Loss/Bleeding1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
AS REPORTED BY THE USER FACILITY: EVENT 1: THE YELLOW RUBBER PLUG IS LOOSE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350825 ↗MalfunctionOct 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
AS REPORTED BY THE USER FACILITY: EVENT 1: THE YELLOW RUBBER PLUG IS LOOSE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350794 ↗MalfunctionOct 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
AS REPORTED BY THE USER FACILITY: EVENT 3: THE YELLOW RUBBER PLUG IS LOOSE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350772 ↗MalfunctionOct 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
AS REPORTED BY THE USER FACILITY: EVENT 2: THE YELLOW RUBBER PLUG IS LOOSE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350751 ↗MalfunctionOct 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
AS REPORTED BY THE USER FACILITY: EVENT 2: THE YELLOW RUBBER PLUG IS LOOSE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350701 ↗MalfunctionOct 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
AS REPORTED BY THE USER FACILITY: EVENT 3: THE YELLOW RUBBER PLUG IS LOOSE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350700 ↗MalfunctionNov 21, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SET CRACKED AND LEAKED BLOOD. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15833426 ↗MalfunctionJun 24, 2022Detachment of Device or Device Component; Free or Unrestricted Flow; Detachment of Device or Device Component; Free or Unrestricted Flow
AS REPORTED BY THE USER FACILITY: WHEN SLIDING THE CLAMP TO STOP THE FLOW, THE FLOW DOES NOT STOP. ALSO, WHEN THE CLAMP IS RELEASED, IT APPEARS THAT THE TUBING HAS BEEN CUT BY THE CLAMP. THE RUBBER STOPPER ON THE "NEEDLE" IV PORT HAS POPPED OFF DURING THE INJECTION, EFFECTING THE CONTRAST INJECTION. QUESTION THE SAFETY OF THE PRESSURE RATING/COMPATIBILITY FOR THE POWER INJECTOR. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14798320 ↗MalfunctionAug 11, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THREAD PARTICLES WERE FOUND IN THE GREEN CONNECTOR. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10394112 ↗MalfunctionJul 16, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE LUER LOCK CONNECTOR OF THE EXTENSION LINE WAS RIPPED AND BLOOD LEAKED.
Patient problems: Blood Loss
MAUDE report 8793007 ↗MalfunctionMay 28, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: "WHEN THE USER OPENED THE PRODUCT TO USE, THEY FOUND A BLACK PARTICLE IN THE CAP CONNECTED TO THE EXTENSION TUBE." NO INJURY REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8646220 ↗MalfunctionOct 3, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: END USER REPORTS THAT A CRACK WAS FOUND AT AROUND THE FEMALE LUER, AND BLOOD LEAKAGE WAS NOTED. NO INJURIES REPORTED.
Patient problems: Blood Loss
MAUDE report 7929536 ↗MalfunctionOct 3, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: END USER REPORTS THAT A CRACK WAS FOUND AT AROUND THE FEMALE LUER, AND BLOOD LEAKAGE WAS NOTED. NO INJURIES REPORTED.
Patient problems: Blood Loss
MAUDE report 7929534 ↗MalfunctionSep 6, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE NURSE FOUND BLOOD LEAKAGE ON THE LINEN, LEAKAGE WAS FOUND AT THE T-PORT CONNECTOR. THE NURSE TRIED TO RECONNECT THE CONNECTOR, BUT BLOOD STILL LEAKED. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7851308 ↗MalfunctionJul 23, 2018Leak/Splash; Leak/Splash
AS REPORTED BY USER FACILITY: WHILE ADMINISTERING THE ELECTROLYTE SOLUTION TO A NICU PATIENT, THE NURSE FOUND THAT THE FEMALE LUER WAS CRACKED CAUSING ABOUT 5ML OF BLOOD TO LEAK.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 7710344 ↗MalfunctionApr 3, 2018Fluid/Blood Leak; Fluid/Blood Leak
WHILE ADMINISTERING THE ELECTROLYTE SOLUTION TO A NICU PATIENT, THE NURSE FOUND THAT THE FEMALE LUER WAS CRACKED CAUSING ABOUT 5 ML OF BLOOD TO LEAK.
Patient problems: Blood Loss
MAUDE report 7393625 ↗MalfunctionMar 5, 2018Fluid/Blood Leak; Fluid/Blood Leak
WHILE ADMINISTERING THE ELECTROLYTE SOLUTION TO A NICU PATIENT, THE NURSE FOUND THAT THE FEMALE LUER WAS CRACKED CAUSING ABOUT 5 ML OF BLOOD TO LEAK.
Patient problems: Blood Loss
MAUDE report 7313185 ↗InjuryFeb 26, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE PRODUCT IN QUESTION WAS USED FOR ARTERIAL BLOOD SAMPLING LINE. UPON CONNECTING THE PRODUCT TO THE ARTERIAL LINE, THERE WAS BLOOD LEAKAGE FROM THE PRODUCT. BECAUSE THE PATIENT WAS IN NICU AND WAS IN CRITICAL CONDITION, FLUID ADMINISTRATION WAS CONSIDERED FOR THE BLOOD LOSS.
Patient problems: Blood Loss
MAUDE report 7295694 ↗MalfunctionNov 29, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 2. BLOOD WAS FOUND TO BE LEAKING FROM SMALLBORE T-PORT EXTENSION SET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6131815 ↗MalfunctionNov 29, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 1. BLOOD WAS FOUND TO BE LEAKING FROM SMALLBORE T-PORT EXTENSION SET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6131812 ↗
Other Set, administration, intravascular devices
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- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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