MaxGuard ME1032Recalls & reported problems
BD Switzerland Sàrl · Extension Set, (minibore) 15 cm (6 in) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 10885403235979), received between Oct 30, 2018 and Apr 11, 2023 — classified as 2 malfunctions.
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
- Leak/Splash1
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.
MalfunctionApr 11, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BLOOD AND SALINE LEAKED FROM THE BD MAXGUARD¿ EXTENSION SET AFTER ATTACHING THE STOPCOCK, GETTING ONTO THE ECHO KEYBOARD AND TECHNICIAN'S FOREHEAD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IV PLACE FOR BUBBLE STUDY AND DEFINITY. IV WAS PLACE LEFT HAND, PATIENT TOLERATED WELL. BD MAXGUARD EXTENSION SET... WAS ATTACHED ALONG WITH DISCFIX 3-WAY STOPCOCK. IV FLUSHED WELL, HOWEVER WHEN PUSHING AGITATED NORMAL SALINE AFTER ATTACHING 3-WAY STOPCOCK NS MIXED WITH PATIENT BLOOD SPILLED OUT OF THE IV EXTENSION GETTING ECHO KEYBOARD WET AND ECHO TECH XXX REPORTED HE FELT A SPLASH ON HIS FOREHEAD/FACE. REPLACED BD MAXGUARD EXTENSION SET AND DISCFIX 3-WAY STOPCOCK, IV STILL WITH GOOD FLUSH. AND WITH NEW EXTENSION BUBBLE STUDY AND DEFINITY STUDY WAS ABLE TO BE COMPLETED. PATIENT TOLERATED STUDY WELL, REMOVAL OF IV WAS DONE BY ME (XXX). XXX NOTIFIED RN ABOUT INCIDENT WHO INFORMED SUPERVISOR."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16714488 ↗MalfunctionOct 30, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE NURSE NOTED THAT BLOOD WAS BACKING UP INTO THE PATIENT'S ARTERIAL LINE. UPON ASSESSMENT IT WAS FOUND THAT WHILE FLUSHING THE ARTERIAL LINE THE TUBING LEAKED FROM THE JUNCTION OF THE TUBING AND THE FEMALE LUER. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8020040 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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