Blood Administration Set NF5145Recalls & reported problems
B. Braun Medical Inc. · Gravity Blood Administration Set with 1 SafeLine® Injection Site, Pump Chamber · Class 2
All models of Blood Administration Set (24)
Data updated Oct 16, 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 04046964187506), received between Nov 17, 2016 and Nov 17, 2016 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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. 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 Expected3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 1: AFTER SPIKING THE UNIT OF BLOOD AND PRIMING THE INTRAVENOUS (IV) LINE, THE ANESTHESIOLOGIST BEGAN PUMPING THE TUBING WITH HIS HAND AT THE "HAND PUMP" SITE. WHEN HE DID THIS, BLOOD LEAKED OUT OF THE TOP OF THE HAND PUMP SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6109285 ↗MalfunctionNov 17, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 2: AFTER SPIKING THE UNIT OF BLOOD AND PRIMING THE INTRAVENOUS (IV) LINE, THE ANESTHESIOLOGIST BEGAN PUMPING THE TUBING WITH HIS HAND AT THE "HAND PUMP" SITE. WHEN HE DID THIS, BLOOD LEAKED OUT OF THE TOP OF THE HAND PUMP SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6109275 ↗MalfunctionNov 17, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY THE USER FACILITY: EVENT 3. AFTER SPIKING THE UNIT OF BLOOD AND PRIMING THE INTRAVENOUS (IV) LINE, THE ANESTHESIOLOGIST BEGAN PUMPING THE TUBING WITH HIS HAND AT THE "HAND PUMP" SITE. WHEN HE DID THIS, BLOOD LEAKED OUT OF THE TOP OF THE HAND PUMP SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6109240 ↗
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.
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