BD Durasafe Plus, BD Epilor 400287Recalls & reported problems
Becton, Dickinson And Company · DURASAFE+EL CSE M-KIT 27G WHX18G WS PLOR · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382904002879), received between Aug 20, 2021 and Aug 20, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2021Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem
IT WAS REPORTED ANESTHESIA 17GAX18CM DURASAFE BATCH#931973 CONTAINED FOREIGN MATTER AND HAD STERILITY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "BATCH NUMBER 9319737 PACKAGING IS NOT TIGHTLY SEALED, THERE ARE IMPURITIES IN THE PACKAGE" IT WAS REPORTED ANESTHESIA 17GAX18CM DURASAFE BATCH#0220423 CONTAINED FOREIGN MATTER AND HAD STERILITY ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: BATCH NUMBER 0220423 THERE ARE IMPURITIES IN THE PACKAGE" IT WAS REPORTED ANESTHESIA 17GAX18CM DURASAFE BATCH#0220531 HAD A BLOCKED NEEDLE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "BATCH NUMBER 0220531 FILTER IS BLOCKED" IT WAS REPORTED ANESTHESIA 17GAX18CM DURASAFE BATCH#9232400 HAD A DEFECTIVE CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "BATCH NUMBER 9232400 PUNCTURE TUBE AND PRN ARE NOT TIGHTENED." IT WAS REPORTED ANESTHESIA 17GAX18CM DURASAFE BATCH#0220527 CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "BATCH NUMBER 0220527 THERE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12347728 ↗
Other Anesthesia conduction kit devices
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- ARROW IPN922678Teleflex Incorporated · Anesthesia conduction kit2 recalls0 reports
- BD Luer-Lok, BD Glaspak 405672Becton, Dickinson And Company · Anesthesia conduction kit1 recall27 reports
- BD Luer-Lok, BD Glaspak 405673Becton, Dickinson And Company · Anesthesia conduction kit1 recall10 reports
- BD Luer-Lok, BD Glaspak 405637Becton, Dickinson And Company · Anesthesia conduction kit1 recall7 reports
- BD Luer-Lok, BD Glaspak 405707Becton, Dickinson And Company · Anesthesia conduction kit1 recall4 reports
- BD Glaspak 405675Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405609Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 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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