IV Administration Set 354208Recalls & reported problems
B. Braun Medical Inc. · Anesthesia IV Administration Set with 2 CARESITE® Injection Sites and Manifold · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964293818), received between Jun 24, 2019 and Jun 24, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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-0684-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Blood Loss1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS HAVING ISSUES WITH LEAKAGE OF THE IV TUBING AT THE DISTAL END WHERE THE TUBING IS ATTACHED TO THE LUER LOCK. THE IV'S ARE LEAKING SOMEWHERE NEAR THE HUB OF THE CATHETER AND THE LUER LOCK OF THE TUBING. NO INJURY REPORTED.
Patient problems: Blood Loss; No Known Impact Or Consequence To Patient
MAUDE report 8726278 ↗
Other Stopcock, i.V. Set devices
- Connecta, Luer-Lok 394910BD Switzerland Sàrl · Stopcock, i.V. Set3 recalls8 reports
- Outlook® 490361B. Braun Medical Inc. · Stopcock, i.V. Set3 recalls0 reports
- Blood Administration Set 490530B. Braun Medical Inc. · Stopcock, i.V. Set2 recalls11 reports
- Medex MX9341LIcu Medical, Inc. · Stopcock, i.V. Set63 reports
- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- IV Administration Set 490067B. Braun Medical Inc. · Stopcock, i.V. Set1 recall9 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.