Extension Set 471950Recalls & reported problems
B. Braun Medical Inc. · Small bore extension set with distal T-port with male luer slip connector. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04022495770080), received between Nov 23, 2016 and Aug 16, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 16, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS, "LEAKAGE FROM THE CONNECTION WITH THE INFUSION LINE HAD OCCURRED. A CRACK WAS OBSERVED AT THE FEMALE ADAPTOR." ALTHOUGH THERE WAS BLOOD LEAKAGE FROM THE CONNECTION OF THE TUBING, THERE WAS NO ADVERSE REACTION TO THE BABY. THE EXTENSION SET IN QUESTION WAS IMMEDIATELY REPLACED WITH A BRAND NEW ONE, AND THE INFUSION WAS CONTINUED ALL RIGHT.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6798967 ↗MalfunctionNov 23, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY VIA (B)(4): RN DISCOVERED BLOOD BACKED UP INTO THE T CONNECTOR AND BLOOD/TPN/LIPIDS SOAKED BED SHEETS. UPON ASSESSMENT, THE T CONNECTOR WAS FOUND TO BE CRACKED. IV WAS REMOVED AND REPLACED. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6124422 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.