IV Administration Set 490521Recalls & reported problems
B. Braun Medical Inc. · IV ADMIN SET, 15D, 120 IN. · Class 2
All models of IV Administration Set (153)
Data updated Oct 18, 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 04046955185252), received between Mar 19, 2020 and Mar 19, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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 18, 2026.
Recalls naming this device
- Oct 29, 2025Class IIOpen, Classified
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Z-0670-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED VIA MEDWATCH NUMBER (B)(4) : EVENT 2: PER THE MEDWATCH REPORT IT WAS STATED THAT UPON FLUID START UP, THE PATIENT'S HUSBAND NOTICED THAT THERE WAS BLOOD LEAK. THE PATIENT'S IV TUBING CAME OFF AT THE FIRST CONNECTION SITE. A NEW IV SET WAS USED AND THIS SET ALSO DISCONNECTED AND LEAKED. THE MEDWATCH REPORT STATED THAT THE STAFF WAS INFORMED TO TIGHTEN CONNECTIONS ON ALL IV TUBING. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9852810 ↗MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED VIA MEDWATCH NUMBER (B)(4) : EVENT 1: PER THE MEDWATCH REPORT IT WAS STATED THAT UPON FLUID START UP, THE PATIENT'S HUSBAND NOTICED THAT THERE WAS BLOOD LEAK. THE PATIENT'S IV TUBING CAME OFF AT THE FIRST CONNECTION SITE. A NEW IV SET WAS USED AND THIS SET ALSO DISCONNECTED AND LEAKED. THE MEDWATCH REPORT STATED THAT THE STAFF WAS INFORMED TO TIGHTEN CONNECTIONS ON ALL IV TUBING. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9852800 ↗
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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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