MaxGuard MXT1003Recalls & reported problems
BD Switzerland Sàrl · Pressure rated T-connector extension set, (minibore) 15 cm (6 in) · Class 2
All models of MaxGuard (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403237829), received between Nov 26, 2024 and Sep 22, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Activation, Positioning or Separation Problem1
- Disconnection1
- Free or Unrestricted Flow1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Free or Unrestricted Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861493 ↗MalfunctionMay 14, 2025Break; Break
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT SPIN COLLAR ON ITEM # MXT1003 BROKEN. THE SPIN COLLAR FELL OFF COMPLETELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22023499 ↗MalfunctionFeb 23, 2025Break; Break
MalfunctionFeb 13, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21374215 ↗MalfunctionFeb 4, 2025
UPON CONNECTING THE T-CONNECTOR TO IV CATHETER, IT BROKE OFF UPON TWISTING. T-CONNECTOR WAS IMMEDIATELY DISCONNECTED FROM IV CATHETER, NO HARM TO PATIENT. PRODUCT BD MAXGUARD PRESSURE RATED T-CONNECTOR EXTENSION SET (MINIBORE). LOT #24079242.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21303776 ↗MalfunctionNov 26, 2024Disconnection; Disconnection
IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED T-CONNECTOR EXTENSION SET WAS DISCONNECTING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY ARE HAVING MULTIPLE ISSUES WITH THEM BECOMING DISCONNECTED: BD MAXGUARD PRESSURE RATED T-CONNECTOR EXTENSION SET, REF MXT1003.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20787093 ↗MalfunctionNov 26, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED T-CONNECTOR EXTENSION SET WAS DISCONNECTING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING REPORTER IT WAS REPORTED BY CUSTOMER THAT THEY ARE HAVING MULTIPLE ISSUES WITH THEM BECOMING DISCONNECTED: BD MAXGUARD PRESSURE RATED T-CONNECTOR EXTENSION SET, REF MXT1003.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20784004 ↗
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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 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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