NA 2C5647Recalls & reported problems
Baxter International Inc. · Y-Type Catheter Extension Set, 2 Check Valves, Male Luer Lock Adapter with Retractable Collar · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412031569), received between May 3, 2018 and May 3, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
Patient problems
- Respiratory Distress1
- Weakness1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 3, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
A PATIENT WAS USING AN INTRAVENOUS (IV) EXTENSION SET TO INFUSE A POST-OPERATIVE IV OF ACETAMINOPHEN AT A RATE OF 100 OR 200 MILLITERS OVER 15 MINUTES (NO FURTHER DETAIL). IT WAS REPORTED THAT THE BLUE CAP THAT WAS OVER THE ¿OTHER Y-SITE¿ (NOT FURTHER SPECIFIED) WAS NOT TIGHT ONTO THE SITE AND ALLOWED AIR TO ENTER INTO THE LINE DURING THE INFUSION. IT WAS STATED THAT AIR ENTERED THE PATIENT FOR AN UNKNOWN AMOUNT OF TIME (STATED AS APPROXIMATELY 15-60 MINUTES). THE PATIENT WENT INTO RESPIRATORY DISTRESS DUE TO THE EVENT. THE PATIENT WAS GIVEN OXYGEN VIA A CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) MACHINE. NARCAN WAS ALSO ADMINISTERED TO THE PATIENT (DOSE, FREQUENCY AND ROUTE WERE NOT REPORTED). AFTERWARDS, THE PATIENT COMPLAINED OF WEAKNESS IN THEIR LEFT ARM. THE PATIENT'S LEFT ARM FUNCTION EVENTUALLY RETURNED TO NORMAL, AND THE PATIENT RECOVERED FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Respiratory Distress; Weakness
MAUDE report 7484237 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page