MaxPlus MPX9103Recalls & reported problems
BD Switzerland Sàrl · 8 IN KINK RESISTANT EXT SET W/MAX Y · 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 10885403237294), received between Aug 19, 2019 and Dec 30, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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.
Most reported problems
Device problems
- Disconnection1
- Fluid/Blood Leak1
- Material Separation1
- Separation Failure1
Patient problems
- No Information3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation
IT WAS REPORTED THAT A EXTENSION SET TUBING SEPARATED WHEN ATTACHED TO THE PATIENT AT THE POINT OF CONNECTION BETWEEN THE Y-SITE PORT AND THE MALE LUER. IT WAS STILL INSERTED INTO THE PATIENT¿S VEIN. ALTHOUGH REQUESTED, THERE HAS BEEN NO IMPACT TO PATIENT RESPONSE OR ADDITIONAL EVENT INFORMATION MADE AVAILABLE TO DATE.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 9532727 ↗MalfunctionDec 30, 2019Separation Failure; Separation Failure
IT WAS REPORTED THAT AN EXTENSION SET TUBING SEPARATED WHEN ATTACHED TO THE PATIENT, AT THE POINT OF CONNECTION BETWEEN THE Y-SITE PORT AND THE MALE LUER. IT WAS STILL INSERTED IN THE PATIENT¿S VEIN. ALTHOUGH REQUESTED, THERE HAS BEEN NO FURTHER PATIENT OR EVENT INFORMATION MADE AVAILABLE TO DATE.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 9531633 ↗MalfunctionAug 19, 2019Disconnection; Disconnection
IT WAS REPORTED THAT THE ANESTHESIA TEAM IS EXPERIENCING AN UNINTENDED TUBING DISCONNECTION.
Patient problems: No Information
MAUDE report 8908703 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page