MaxZero MZ9327Recalls & reported problems
BD Switzerland Sàrl · Microbore tri-fuse extension set, IV connector 18 cm (7 in) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403427268), received between Jul 1, 2020 and Jul 6, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT EXT SET TRI-FUSE 7 W SLIDE CLAMP TUBING WOULD NOT FLUSH. THIS OCCURRED DON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: MZ9327 BATCH #: UNKNOWN. IT WAS REPORTED ON THE SAME DAY, TWO INCIDENTS PRODUCT FOUND TO NOT FLUSH. TWO INCIDENTS OF PRODUCT MZ9327 FOUND TO NOT FLUSH. THESE WERE BRAND NEW FROM THE PACKAGE AND ONE OF THE LEGS OF THE TRI-FUSE SEEMED FUSED INTERNALLY AND WOULD NOT EVEN PRIME WITH SALINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10233420 ↗MalfunctionJul 1, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE EXT SET TRI-FUSE 7 W SLIDE CLAMP EXPERIENCED DAMAGE/DEFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD ANOTHER INCIDENT TODAY THAT I WAS ABLE TO DOCUMENT WITH PICTURES. THE SAME BABY WHO HAD TO HAVE A NEW CENTRAL LINE PLACED LAST WEEK, WAS FOUND TO HAVE A CRACKED AND LEAKING MZ1000-07 AGAIN TODAY ON HER NEW PICC. THIS DEVICE WAS CONNECTED TO THE HUB OF THE PICC, WHICH WAS CONNECTED TO THE TRI-PORT. WHEN WE BROKE IT ALL DOWN AND REPLACED, THE CRACK WAS VISIBLE AND HOPEFULLY YOU CAN SEE HOW THAT CONTRIBUTED TO THE LEAKING AND LOSS OF TPN AND LIPIDS. CUSTOMER RESPONSE: ARE YOU ABLE TO PROVIDE A DESCRIPTION OF THE ISSUE DETECTED WITH THIS PRODUCT? -I UNDERSTAND THIS EXTENSION SET WAS ATTACHED TO THE NEEDLESS CONNECTOR AND WAS ALSO LEAKING. THE EXTENSION SET DID NOT APPEAR TO BE LEAKING SO THAT HAS NOT BEEN SAVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10222281 ↗
Other Set, administration, intravascular devices
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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