NA 1C8624Recalls & reported problems
Baxter International Inc. · Transfer Set, Two Male Luer Lock Adapters · 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 00085412031842), received between Jul 26, 2019 and Jul 26, 2019 — 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 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.
MalfunctionJul 26, 2019Fluid/Blood Leak; Fluid/Blood Leak
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT AN EXTENSION SET LEAKED BLOOD FROM AN UNSPECIFIED LOCATION DURING INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8832627 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.