MaxGuard MM4000Recalls & reported problems
BD Switzerland Sàrl · 3-Port manifold · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403236488), received between Nov 13, 2025 and Nov 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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.
Reports received per month
Most reported problems
Device problems
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2025Crack; Crack
IT WAS REPORTED THAT THE BD 3-PORT BACK CHECK MANIFOLD WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IV TUBE WAS CRACKED. I DID CONFIRM, WE ARE NOT USING ANY ALCOHOL OR PREP PRODUCT WHEN INITIATING THE MANIFOLD. THE CRACKING HAS BEEN HAPPENING WHEN REMOVING THE IV TUBING FROM THE MANIFOLD AND WHEN TWO MANIFOLDS ARE TOGETHER, AND THE RN IS ATTEMPTING TO SEPARATE. THE PORT IS CRACKING WHEN THIS IS OCCURRING. TYPICALLY, THE DEVICE IS TYPICALLY IN USE BETWEEN 12-20 HOURS. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS: NO INJURY TO PATIENT. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? NO LOT# ON PRODUCT, WE DON'T HAVE THE PACKAGE IT CAME IN. WAS THERE ANY LEAKAGE? IF SO, WHAT WAS THE FLUID AT THE TIME OF USE? THERE WAS LEAKAGE AT THE PORT WHERE THE IV TUBING BROKE OFF. OUR NURSE DID CHANGE THIS OUT IN REAL TIME AND THERE WAS NO REAL PATIENT HARM THANKFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23546771 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.