ULTRASITE® 473438Recalls & reported problems
B. Braun Medical Inc. · Small Bore Extension Set with ULTRASITE® Valve · Class 2
All models of ULTRASITE (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This B. Braun Ultrasite small bore extension set is a short length of tubing with a valve, used to administer IV medicines and chemotherapy. The 48 reports mostly describe connectors and caps coming loose during use, letting fluid or blood leak or spill, with the set sometimes not working as expected; reports describe minor blood loss and one chemotherapy spill, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 04022495770295), received between Nov 23, 2016 and Oct 8, 2024 — classified as 48 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (26 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.
Reports received per month
Most reported problems
Device problems
- Device Operates Differently Than Expected26
- Fluid/Blood Leak14
- Leak/Splash8
Patient problems
- No Consequences Or Impact To Patient40
- Chemical Exposure4
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2024Leak/Splash; Leak/Splash
AS REPORTED, THE WHITE CONNECTOR IS NOT STAYING ON THE LUER LOCK END, EVEN AFTER TIGHTENING IT HAS COME LOOSE ON MORE THAN A COUPLE OF OCCASIONS AND HAS CAUSED A CHEMO SPILL ON ONE OCCASION.
Patient problems: Chemical Exposure
MAUDE report 20398503 ↗MalfunctionOct 8, 2024Leak/Splash; Leak/Splash
AS REPORTED, EVENT 1 THE WHITE CONNECTOR IS NOT STAYING ON THE LUER LOCK END, EVEN AFTER TIGHTENING IT HAS COME LOOSE ON MORE THAN A COUPLE OF OCCASIONS AND HAS CAUSED A CHEMO SPILL ON ONE OCCASION.
Patient problems: Chemical Exposure
MAUDE report 20398448 ↗MalfunctionOct 8, 2024Leak/Splash; Leak/Splash
AS REPORTED, EVENT 4: THE WHITE CONNECTOR IS NOT STAYING ON THE LUER LOCK END, EVEN AFTER TIGHTENING IT HAS COME LOOSE ON MORE THAN A COUPLE OF OCCASIONS AND HAS CAUSED A CHEMO SPILL ON ONE OCCASION.
Patient problems: Chemical Exposure
MAUDE report 20398395 ↗MalfunctionOct 8, 2024Leak/Splash; Leak/Splash
AS REPORTED, THE WHITE CONNECTOR IS NOT STAYING ON THE LUER LOCK END, EVEN AFTER TIGHTENING IT HAS COME LOOSE ON MORE THAN A COUPLE OF OCCASIONS AND HAS CAUSED A CHEMO SPILL ON ONE OCCASION.
Patient problems: Chemical Exposure
MAUDE report 20398381 ↗MalfunctionApr 17, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: THE IV CATHETERS COMING LOOSE OR COMPLETELY UNDONE AND PATIENTS ACTUALLY BLEEDING FROM THE DISCONNECTION. MINOR BLOOD LOSS ON OCCASION OR LEAKING FLUIDS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16755980 ↗MalfunctionApr 17, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 3: THE IV CATHETERS COMING LOOSE OR COMPLETELY UNDONE AND PATIENTS ACTUALLY BLEEDING FROM THE DISCONNECTION. MINOR BLOOD LOSS ON OCCASION OR LEAKING FLUIDS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16755979 ↗MalfunctionApr 17, 2023Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: THE IV CATHETERS COMING LOOSE OR COMPLETELY UNDONE AND PATIENTS ACTUALLY BLEEDING FROM THE DISCONNECTION. MINOR BLOOD LOSS ON OCCASION OR LEAKING FLUIDS. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16755978 ↗MalfunctionMar 29, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: WE HAVE USED THE BRAUN SMALLBORE EXTENSION SET WHEN WE START IV'S FOR YEARS. THE PAST FEW MONTHS, WE HAVE EXPERIENCED THE WHITE INJECTION CAPS COMING LOOSE FROM THE TUBING BEFORE AND EVEN DURING THE INFUSION. I HAD ONE TODAY THAT I MADE SURE WAS TIGHT, THEN IT FELL OFF AT THE END OF THE INFUSION. IT IS VERY DISTURBING BECAUSE THE CHEMO IS COMING OUT ONE END AND BLOOD FROM THE PATIENT COMING OUT THE OTHER END."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13944737 ↗MalfunctionMar 30, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EXTENSION SET DETACHED CAUSING BLOOD LEAKAGE. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6446133 ↗MalfunctionFeb 3, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: ONCE THE ITEM WAS PLACED ON THE PATIENT IT UNSCREWED ITSELF AND FELL OFF, BLOOD GOT ON THE PATIENT, THE NURSE, THE FLOOR AND CHAIR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6299884 ↗MalfunctionFeb 1, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 11. IV EXTENSION SET IS LEAKING BLOOD WHERE IT CONNECTS TO THE IV CATHETER HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292538 ↗MalfunctionFeb 1, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 12: IV EXTENSION SET IS LEAKING BLOOD WHERE IT CONNECTS TO THE IV CATHETER HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292533 ↗MalfunctionFeb 1, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 10. IV EXTENSION SET IS LEAKING BLOOD WHERE IT CONNECTS TO THE IV CATHETER HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292524 ↗MalfunctionFeb 1, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 9: IV EXTENSION SET IS LEAKING BLOOD WHERE IT CONNECTS TO THE IV CATHETER HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292520 ↗MalfunctionFeb 1, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 8. IV EXTENSION SET IS LEAKING BLOOD WHERE IT CONNECTS TO THE IV CATHETER HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292517 ↗MalfunctionFeb 1, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 7: IV EXTENSION SET IS LEAKING BLOOD WHERE IT CONNECTS TO THE IV CATHETER HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292515 ↗MalfunctionFeb 1, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 6: IV EXTENSION SET IS LEAKING BLOOD WHERE IT CONNECTS TO THE IV CATHETER HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292513 ↗MalfunctionFeb 1, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 5. IV EXTENSION SET IS LEAKING BLOOD WHERE IT CONNECTS TO THE IV CATHETER HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292510 ↗MalfunctionFeb 1, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 4. IV EXTENSION SET IS LEAKING BLOOD WHERE IT CONNECTS TO THE IV CATHETER HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292508 ↗MalfunctionFeb 1, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 2: IV EXTENSION SET IS LEAKING BLOOD WHERE IT CONNECTS TO THE IV CATHETER HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292503 ↗MalfunctionFeb 1, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 3: IV EXTENSION SET IS LEAKING BLOOD WHERE IT CONNECTS TO THE IV CATHETER HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292502 ↗MalfunctionFeb 1, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: EVENT 1: IV EXTENSION SET IS LEAKING BLOOD WHERE IT CONNECTS TO THE IV CATHETER HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6292490 ↗MalfunctionNov 29, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 24. BLOOD TINGED SALINE LEAKING OUT BY THE INJECTION PORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6131806 ↗MalfunctionNov 29, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 25. BLOOD TINGED SALINE LEAKING OUT BY THE INJECTION PORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6131804 ↗MalfunctionNov 29, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: EVENT 23: BLOOD TINGED SALINE LEAKING OUT BY THE INJECTION PORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6131801 ↗
Other Set, administration, intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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