IV Administration Set V1500Recalls & reported problems
B. Braun Medical Inc. · IV/Y-TY/FLSHTB/DC/RC · 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 04046964188510), received between Dec 5, 2018 and Feb 21, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS THAT THE PRODUCT WAS LEAKING AT THE Y-SITE DURING ADMINISTRATION OF KYMRIAH NOVARTIS. THE AMOUNT OF MEDICATION BEING INFUSED WAS VERY SMALL (14 CC), AND THE LEAK WAS A MINIMAL AMOUNT FROM THE SIDE OF THE TUBING CONTAINING THE NS SO THE PATIENT DECLINED TO HAVE THE TUBING CHANGED. KYMRIAH INFUSION WAS COMPLETED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8359498 ↗MalfunctionDec 5, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE IV SET LEAKED BLOOD DURING USE. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8133448 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.