BD Safety-Lok™ Infusion Set with Filter 47260025Recalls & reported problems
Becton, Dickinson And Company · SAFETY LOK INFUSION SET WITH FILTER · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382904726003), received between Jan 17, 2018 and Oct 9, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Complete Blockage” (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 18, 2026.
Most reported problems
Device problems
- Complete Blockage1
- Leak/Splash1
- Restricted Flow rate1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Low Blood Pressure/ Hypotension1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 9, 2020Complete Blockage; Restricted Flow rate; Leak/Splash; Complete Blockage; Restricted Flow rate; Leak/Splash
IT WAS REPORTED THAT THE SAFETY LOK INFUSION SET WITH FILTER PROGRAM "FROZE" AND BECAME NONFUNCTIONAL, CAUSING HYPOTENSION, AND A DELAY IN TREATMENT TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "E2321 - LOW BLOOD PRESSURE/HYPOTENSION F23 - UNEXPECTED MEDICAL INTERVENTION F05 - DELAY TO TREATMENT/THERAPY A110201 - APPLICATION PROGRAM FREEZES, BECOMES NONFUNCTIONAL."
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 10659359 ↗MalfunctionJan 17, 2018Tear, Rip or Hole in Device Packaging
IT WAS REPORTED BEFORE USE OF THE BD INTIMA-II CATHETER UPON VISUAL INSPECTION THERE WERE TEARS OBSERVED ON TWO PRIMARY PACKAGES OF THE INFUSION SET OF THE FINAL PACKAGED PRODUCT THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7200165 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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