MaxGuard MX5302Recalls & reported problems
BD Switzerland Sàrl · Pressure rated extension set, (minibore) with needleless Y-site 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
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885403237560), received between May 17, 2023 and Jun 26, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Leak/Splash3
- Fluid/Blood Leak2
- Defective Component1
- Disconnection1
- Material Separation1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2026Disconnection
IT WAS REPORTED THAT THE BD MAXGUARD PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SITE KEEPS COMING UNHOOKED FROM THE PATIENTS. IT HAS HAPPENED 3 TIMES. INJURIES OR ADVERSE EVENT: YES. ITEM: MX5302, QUANTITY AFFECTED: 3 EA, SERIAL/LOT NUMBER: (B)(6), ARE SAMPLES POTENTIALLY CONTAMINATED OR BIOHAZARD? N/A.
Patient problems: Insufficient Information
MAUDE report 25640521 ↗MalfunctionJun 8, 2026Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED EXTENSION SET WAS SEPARATEDTHE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIMIT WAS REPORTED BY CUSTOMER THAT "INFUSION SET'S TUBING MAY SEPARATE, LEAK, OR FAIL TO PRIME"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25437686 ↗MalfunctionMar 3, 2026Break; 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 THE CUSTOMER THAT HAD 2 INSTANCES IN THE SAME DAY WITH THIS SPECIFIC LOT OF THE TUBING FAILING AND LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24499884 ↗MalfunctionMar 3, 2026Product Quality Problem
IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT HAD 2 INSTANCES IN THE SAME DAY WITH THIS SPECIFIC LOT OF THE TUBING FAILING AND LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24499880 ↗MalfunctionFeb 20, 2026Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404498 ↗MalfunctionFeb 20, 2026Fluid/Blood Leak
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404304 ↗MalfunctionAug 15, 2025Break; Break
IT WAS REPORTED THAT THE BD SPECIALTY LOW-PRESSURE EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MALE LUER ON THE BD ALARIS PUMP INFUSION SET (REF. (B)(4) BROKE OFF IN FEMALE Y-SITES ON THE BD MAXGUARD PRESSURE RATED EXTENSION SET (MINIBORE) WITH NEEDLESS Y-SITE (REF (B)(4)). ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THERE WERE NO REPORTS OF PT HARM OR INJURY. THE STAFF INVOLVED IN THE CARE OF THE PT HAD TO REPLACE THE IV TUBING WITH NEW SUPPLIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22822487 ↗MalfunctionAug 15, 2025Break; Break
IT WAS REPORTED THAT THE BD SPECIALTY LOW-PRESSURE EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MALE LUER ON THE BD ALARIS PUMP INFUSION SET (REF. (B)(4)) BROKE OFF IN FEMALE Y-SITES ON THE BD MAXGUARD PRESSURE RATED EXTENSION SET (MINIBORE) WITH NEEDLESS Y-SITE (REF (B)(4)). ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. THERE WERE NO REPORTS OF PT HARM OR INJURY. THE STAFF INVOLVED IN THE CARE OF THE PT HAD TO REPLACE THE IV TUBING WITH NEW SUPPLIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22822486 ↗MalfunctionAug 8, 2023Material Separation; Defective Component; Material Separation; Defective Component
NO ADDTIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17484371 ↗MalfunctionMay 17, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXGUARD PRESSURE RATED EXTENSION SET WITH Y-SITE(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTENSION SET AT CONNECTION TO IV CATHETER (20G) WHILE INFUSING NORMAL SALINE VIA LIFEFLOW, NURSE DOUBLE CHECKED THAT EXTENSION SET WAS SCREWED IN ALL THE WAY AND CORRECTLY INTO IV CATHETER. EXTENSION SET WAS REMOVED AND REPLACED, NO FURTHER LEAKING OR ISSUES WITH NEW EXTENSION SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16948416 ↗
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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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