Extension Set 490203Recalls & reported problems
B. Braun Medical Inc. · EXTENSION SET W/ 2 CARESITE, 14 IN. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964303869), received between Oct 9, 2018 and Oct 9, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING USE OF THE EXTENSION SET LEAKED BLOOD. THE LEAKING IS OCCURRING AT THE CONNECTION OF THE LUER ENDING OF THE EXTENSION SET AND THE PATIENT'S CATHETER HUB. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7949040 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.