IV Administration Set 457515Recalls & reported problems
B. Braun Medical Inc. · Anesthesia IV Set With three CARESITE® Injection Sites, ULTRAPORT™ Zer0 High-Flow, 4-Way Stopcock, and Dual Port SAFEPORT™ · Class 2
All models of IV Administration Set (153)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964716188), received between Jun 22, 2022 and Aug 27, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Oct 29, 2025Open, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0651-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination /Decontamination Problem1
- Leak/Splash1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER DESCRIPTION OF THE EVENT BEING REPORTED: AFTER THE NURSE ATTACHED THE TUBING TO THE IV BAG, THE NURSE SAW SOMETHING MOVING IN THE LINE. THE NURSE IMMEDIATELY REMOVED THE TUBING (IT HAD NOT BEEN USED ON A PATIENT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22905573 ↗MalfunctionJun 22, 2022Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE TUBING WAS BROKEN ON BOTH SIDES OF THE MANIFOLD. THE PATIENT LOST SEVERAL CC'S OF BLOOD AND OF COURSE IV FLUID ON THE FLOOR WHEN THE OTHER NURSE WALKED IN THE ROOM. NO INJURY REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14774569 ↗
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 · each recall links to the FDA recall notice
- 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