Extension Set 456522Recalls & reported problems
B. Braun Medical Inc. · ANES SET W/TRIPLE LL SAFEPORT MANIFOLD · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964296734), received between Jan 19, 2022 and Jan 19, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Free or Unrestricted Flow” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Oct 29, 2025Open, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0637-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Free or Unrestricted Flow2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2022Free or Unrestricted Flow; Free or Unrestricted Flow
AS REPORTED BY THE USER FACILITY: EVENT 2: DETAILED INQUIRY DESCRIPTION SAFEPORT TRIPLE MANIFOLD ITEM #456522, LOT# 0061745719 IS NOT CUTTING OFF THE FLOW OF MEDICATION TO PORTS THAT ARE CLOSED, ALLOWING IT TO KEEP INFUSING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13289467 ↗MalfunctionJan 19, 2022Free or Unrestricted Flow; Free or Unrestricted Flow
AS REPORTED BY THE USER FACILITY: EVENT 1: DETAILED INQUIRY DESCRIPTION SAFEPORT TRIPLE MANIFOLD ITEM #456522, LOT# 0061745719 IS NOT CUTTING OFF THE FLOW OF MEDICATION TO PORTS THAT ARE CLOSED, ALLOWING IT TO KEEP INFUSING. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13289461 ↗
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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.