MaxGuard ME5302Recalls & reported problems
BD Switzerland Sàrl · Pressure Rated Extension Set, 16cm (6.5in) · Class 2
All models of MaxGuard (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403236310), received between Jan 14, 2020 and Sep 17, 2023 — classified as 1 injury, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2023Material Separation; Material Separation
IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED EXTENSION SET CAME APART WHERE IT SHOULD BE PERMANENTLY CONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIBE THE EVENT OR PROBLEM: TUBING OF IV T-CONNECTOR CAME APART WHERE IT USUALLY IS PERMANENTLY CONNECTED TO THE DEVICE THAT CONNECTS THE IV CATHETER HUB TO THE PRIMARY TUBING. THE PATIENT LOST APPROXIMATELY 1-2 ML OF BLOOD FROM THE BROKEN TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17762500 ↗MalfunctionJan 14, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN INTRAVENOUS LIPIDS (IL) INFUSION WAS LEAKING AFTER A NEW TUBING WAS HUNG FOR A NIGHT TIME FLUID CHANGE. THE TUBING WAS THEN INSPECTED AND TRACED THE SET ALL THE WAY DOWN TO THE PATIENT'S SIDE AND THE IT WAS DRY. IT WAS NOTED THAT IL WAS INFUSING THROUGH SYRINGE PUMP. THE TUBING WAS DISCONNECTED FROM THE PATIENT AND THE DOCTOR WAS NOTIFIED. THE INFUSION WAS STOPPED AS THE PHARMACY DOES NOT MAKE INTRAVENOUS LIPIDS AT NIGHT. THE EVENT OCCURRED IN NEONATAL INTENSIVE CARE UNIT. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9588719 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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