Safsite® 472060Recalls & reported problems
B. Braun Medical Inc. · ET116L SM BORE EXT SET 7-1/2 IN. · Class 2
All models of Safsite (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04046964184697), received between Nov 21, 2016 and Jan 6, 2021 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (9 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
Device problems
- Device Operates Differently Than Expected9
- Fluid/Blood Leak2
Patient problems
- No Consequences Or Impact To Patient9
- Exposure to Body Fluids1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2021Fluid/Blood Leak; Fluid/Blood Leak
BLOOD LEAKAGE WAS REPORTED FROM THE EXTENSION SET. AS REPORTED BY THE USER FACILITY: THE DEVICE LEAKED AT THE EXTENSION PIPE JOINT. THE IV AND IC CONNECTOR SLIPPED SEVERAL TIMES, AFFECTING THE PATIENT'S QUALITY OF SLEEP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11124410 ↗MalfunctionMar 11, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT IT APPEARS THAT MOVEMENT FROM THE PATIENT CAUSES THE CONNECTION TO LOOSEN, ALLOWING BLOOD, FLUIDS, AND MEDS TO RUN FREELY OUT ONTO THE FLOOR AND ANYONE NEAR. THE PART OF THE SET THAT SCREW INTO THE LUER LOCK SAFESITE CAP, IS CHECKED AT LEAST TWICE, IF NOT MORE, FOR TIGHTNESS. THE PATIENT HAD HEP C. NO HARM CAME TO THE PATIENT IN THIS CASE, HOWEVER, THEIR BLOOD SPEWED OUT ONTO ONE OF THE NURSES. NO INJURY REPORTED.
Patient problems: Exposure to Body Fluids; No Known Impact Or Consequence To Patient
MAUDE report 9817490 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 1. BLOOD BACKED UP TO THE CONNECTION OF THE SAFSITE AND THE EXTENSION SET AND LEAKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124530 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 3: BLOOD BACKED UP TO THE CONNECTION OF THE SAFSITE AND THE EXTENSION SET AND LEAKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124521 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 2: BLOOD BACKED UP TO THE CONNECTION OF THE SAFSITE AND THE EXTENSION SET AND LEAKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124519 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 5: LEAKING AT THE CONNECTION WITH THE TUBING AND THE SAFSITE. LEAK BLOOD ALL OVER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120353 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 4. LEAKING AT THE CONNECTION WITH THE TUBING AND THE SAFSITE. LEAK BLOOD ALL OVER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120344 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 3. LEAKING AT THE CONNECTION WITH THE TUBING AND THE SAFSITE. LEAK BLOOD ALL OVER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120339 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 2. LEAKING AT THE CONNECTION WITH THE TUBING AND THE SAFSITE. LEAK BLOOD ALL OVER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120335 ↗MalfunctionNov 22, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 1. LEAKING AT THE CONNECTION WITH THE TUBING AND THE SAFSITE. LEAK BLOOD ALL OVER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6120330 ↗MalfunctionNov 21, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: THERE WAS LEAKAGE ON THE TUBE AND THE BLOOD WOULD BE LEAKED FROM THE CONNECTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6118277 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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