Blood Administration Set NF5140Recalls & reported problems
B. Braun Medical Inc. · Gravity Blood Administration Set with 1 SafeLine® Injection Site · Class 2
All models of Blood Administration Set (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046964187483), received between Jun 21, 2018 and Nov 16, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Nov 20, 2019Terminated
Potential for leakage at the joint between the blood filters and tubing
Z-0940-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak4
- Contamination /Decontamination Problem1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY, "A BROWN SPOT WAS FOUND ON THE FILTER PORTION OF THE MATERIAL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10843636 ↗MalfunctionSep 27, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DURING SPIKING, PRIOR TO USE ON PATIENT, THE PRODUCT LEAKED. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9131107 ↗MalfunctionAug 12, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER REPORTED TWO DIFFERENT ISSUES WITH THE BLOOD TUBING LEAKING FROM ONE SIDE OR THE OTHER. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8883044 ↗MalfunctionAug 12, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER REPORTED TWO DIFFERENT ISSUES WITH THE BLOOD TUBING LEAKING FROM ONE SIDE OR THE OTHER. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8883043 ↗MalfunctionJun 21, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: THE BLOOD SET MALFUNCTIONED DURING INFUSION OF A CELL THERAPY PRODUCT (THAWED APHERESIS). PRODUCT WAS BEING RINSED WITH SALINE WHEN TUBING CAME OUT OF THE FILTER. NO INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7626737 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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