MaxPlus, MaxGuard MPXT5302-CRecalls & reported problems
BD Switzerland Sàrl · Pressure rated T-connector extension set, (minibore) with clear needleless connector 19 cm (7.5 in) · Class 2
All models of MaxPlus, MaxGuard (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10885403274657), received between Sep 5, 2024 and Aug 4, 2025 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (14 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
- Leak/Splash14
- Material Separation3
- Separation Problem2
- Defective Component1
- Disconnection1
Patient problems
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT LEAKAGE OCCURRED REPORTED BETWEEN THE MAXZERO CONNECTOR AND THE J-LOOP EXTENSION SET DURING A POWER INJECTION IN CT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22709979 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709978 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709976 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709973 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709972 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709970 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709968 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD (B)(6) - 7.5 IN MINIBORE PRESSURE RATED W/T-CONN LEAKED AT A CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER, THERE HAVE BEEN SUBJECTIVE CONCERNS WITH THE PRODUCT IN UP TO 70% OF POWER INJECTION ATTEMPTS. THEY PROVIDED 12 DOCUMENTED EXAMPLES FROM STAFF, ALL INVOLVING CT PROCEDURES WHERE LEAKAGE OCCURRED DURING POWER INJECTION. THE LEAKAGE WAS OBSERVED EITHER AT THE CONNECTION BETWEEN THE CATHETER HUB AND THE J-LOOP EXTENSION SET OR BETWEEN THE J-LOOP AND THE MAXPLUS. IN THIS SPECIFIC CASE, LEAKAGE WAS REPORTED BETWEEN THE INSYTE AG CATHETER HUB AND THE J-LOOP EXTENSION SET DURING A POWER INJECTION IN CT. WHILE NO SPECIFIC INJECTION RATES, GAGE SIZES OR PSI VALUES WERE PROVIDED, THE CUSTOMER CONFIRMED THAT THEY DO NOT EXCEED 325 PSI DURING THESE PROCEDURES. (B)(6) 2025. SHE HAS MENTIONED SHE DOESN¿T HAVE ANY ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 22709967 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709966 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT LEAKAGE OCCURRED REPORTED BETWEEN THE MAXZERO CONNECTOR AND THE J-LOOP EXTENSION SET DURING A POWER INJECTION IN CT.
Patient problems: Insufficient Information
MAUDE report 22709965 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709624 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22708425 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE LEAKAGE OCCURRED BETWEEN THE MAXZERO CONNECTOR AND THE J-LOOP EXTENSION SET DURING A POWER INJECTION IN CT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22708424 ↗MalfunctionOct 22, 2024Material Separation; Separation Problem; Material Separation; Separation Problem
IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED T-CONNECTOR EXTENSION SET WITH NEEDLELESS CONNECTOR WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: PLEASE SEE BELOW EXTENSION SET WE SPOKE ABOUT EARLIER. AS YOU CAN SEE FROM THE PICTURE BELOW, THE ISSUE WE ARE HAVING IS THE PIECE WITH THE LURE LOCK COUPLER COMING APART FROM THE T CONNECTOR, FAIRLY EASILY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20502632 ↗MalfunctionOct 22, 2024Material Separation; Separation Problem; Material Separation; Separation Problem
IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED T-CONNECTOR EXTENSION SET WITH NEEDLELESS CONNECTOR WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE ISSUE HAVING IS THE PIECE WITH THE LURE LOCK COUPLER COMING APART FROM THE T CONNECTOR, FAIRLY EASILY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20502473 ↗MalfunctionSep 17, 2024Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED T-CONNECTOR EXTENSION SET WITH NEEDLELESS CONNECTOR SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT SPIN COLLAR ON T-CONNECTOR COMES OFF EASIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20241741 ↗MalfunctionSep 17, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED T-CONNECTOR EXTENSION SET WITH NEEDLELESS CONNECTOR SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: SPIN COLLAR ON T-CONNECTOR COMES OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20241070 ↗MalfunctionSep 5, 2024Disconnection; Disconnection
IT WAS REPORTED THAT BD EXTENSION SET WAS DISCONNECTING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: CUSTOMER NOTED: WE ARE HAVING AN ISSUE WHERE A PIECE OF THIS IV TUBING KEEPS BREAKING AND COMING APART. HUGE ISSUE, NOT ONLY WITH CONTAMINATION, BUT IF IT FALLS APART WHEN CONNECTED TO A PATIENT AND THE ARMS ARE OUT OF OUR REACH/VISUALIZATION IN SURGERY, IT CAN LEAD TO EXSANGUINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20150436 ↗
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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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