MaxZero MZ5306Recalls & reported problems
BD Switzerland Sàrl · Minibore pressure rated extension set, IV connector, no clamp 18 cm (7.0 in) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403230592), received between Aug 30, 2018 and Sep 24, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Blocked Connection” (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
- Blocked Connection1
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Blocked Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890861 ↗MalfunctionMay 21, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE MINIBORE PRESSURE, IV CONNECTOR NO CLAMP TUBING WAS CRACKED AND LEAKED MEDICINE DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE DOING ASSESSMENT I NOTICED SOME DROPLETS ON THE MALE CONNECTOR OF REMODULIN. I LOOKED CLOSER THINKING IT WAS MAYBE SMALL AIR BUBBLES AND MY GLOVE LOOKED WET. I EVALUATED CLOSER AND NOTICED A CRACK ON THE MAX ZERO OF THE MALE CONNECTOR. I SWITCHED THE CONNECTOR AND REQUESTED A NEW SYRINGE. THE MAX ZERO HAD CRACKED AT THE SEAM. NOT MUCH HAD BEEN LOST WHEN I EVALUATED THE FLOOR, BUT UNSURE OF HOW LONG IT WAS LEAKING. I CONTINUOUSLY CHECKED THE LINE AND A FEW HOURS LATER NOTICED MY GLOVE WAS SLIGHTLY WET WHEN RECHECKING, BUT THIS TIME I NOTICED IT ON THE REGULAR STRAIGHT LINE TUBING. AT THIS TIME THIS TUBING HAD NOT BEEN CHANGED ONLY THE CONNECTOR MALE PIECE HAD BEEN CHANGED. I CHANGED THE ENTIRE LINE AT THIS MOMENT AND THIS STRAIGHT TUBING ALSO NOTED TO HAVE A CRACK AT THE SEAM AS WELL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11867545 ↗MalfunctionAug 30, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE NIGHT RN NOTED PGE LEAKING AT THE "PIGTAIL". THE NURSE HAD TO REQUEST A NEW PGE FROM PHARMACY AND REPLACE THE TUBING THE PGE WAS INFUSING THROUGH. THE CUSTOMER LATER REPORTED THE "PIGTAIL" IS A MZ5306. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7833029 ↗
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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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