Portex A3391-25Recalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00351688069286), received between Feb 19, 2016 and May 11, 2018 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Defective Device” (4 reports).
7 other recalls cover devices cleared under the same FDA submission (K965017); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Defective Device4
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Consequences Or Impact To Patient4
- Awareness During Anesthesia2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT THE BUPIVACAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY WAS INEFFECTIVE. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508153 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT THE BUPIVACAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY WAS INEFFECTIVE. THE PATIENT REQUIRED GENERAL ANESTHESIA AS A RESULT OF THIS INCIDENT. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507938 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT THE HOSPITAL HAD A DRUG FAILURE INCIDENT WITH BUPVIVAINE HCL 0.75% THAT WAS PART OF THE SPINAL TRAY. THERE WERE NO ALLEGATIONS OF OF MALFUNCTION WITH RESPECT TO THE OTHER COMPONENTS OF THE KIT. THE TRAY WAS DISCARDED AND A LOT NUMBER WAS NOT PROVIDED. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED BY THE USER FACILITY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507753 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT THE HOSPITAL HAD A DRUG FAILURE INCIDENT WITH BUPVIVAINE HCL 0.75% THAT WAS PART OF THE SPINAL TRAY. THERE WERE NO ALLEGATIONS OF MALFUNCTION WITH RESPECT TO THE OTHER COMPONENTS OF THE KIT. THE TRAY WAS DISCARDED AND A LOT NUMBER WAS NOT PROVIDED. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED BY THE USER FACILITY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507679 ↗InjuryFeb 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
USER FACILITY REPORTED THAT THE DEVICE WAS PLACED IN USE WITH PATIENT FOR SPINAL ANESTHESIA BUT THE DRUG DID NOT TAKE EFFECT. ACCORDING TO REPORTER, THE PROCEDURE REQUIRED GENERAL ANESTHESIA DUE TO THIS ISSUE. NO PERMANENT ADVERSE EFFECTS TO PATIENT REPORTED.
Patient problems: Awareness During Anesthesia
MAUDE report 5449486 ↗InjuryFeb 19, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
USER FACILITY REPORTED THAT THE DEVICE WAS PLACED IN USE WITH PATIENT FOR SPINAL ANESTHESIA BUT THE DRUG DID NOT TAKE EFFECT. ACCORDING TO REPORTER, THE PROCEDURE REQUIRED GENERAL ANESTHESIA DUE TO THIS ISSUE. NO PERMANENT ADVERSE EFFECTS TO PATIENT REPORTED.
Patient problems: Awareness During Anesthesia
MAUDE report 5449198 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K965017. One submission often covers many models, so check the product and lot details in each record.
- Z-1101-2026 · Dec 19, 2025 · Open, ClassifiedPortex Spinal Tray, Item No. A3729-24 A3595
- Z-0211-2007 · Oct 27, 2006 · TerminatedPortex Continuous Epidural tray Ref 4948-17
- Z-0245-06 · Nov 17, 2005 · Terminated4950-16 Portex Epidural Mini-pack
- Z-0243-06 · Nov 17, 2005 · Terminated4903 Glass L.O.R. Syringe
- Z-0242-06 · Nov 17, 2005 · Terminated4902 Glass L.O.R. Syringe
- Z-0244-06 · Nov 17, 2005 · Terminated4904 Glass L.O.R. Syringe
- Z-0166-04 · Oct 10, 2003 · TerminatedPortex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20
Other Anesthesia conduction kit devices
- BD Luer-Lok, BD Glaspak 405671Becton, Dickinson And Company · Anesthesia conduction kit1 recall68 reports
- 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 Luer-Lok, BD Glaspak 405609Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405735Becton, 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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