Portex NEPI-NLD-15597-20Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15019517115697), received between Jan 30, 2018 and Sep 19, 2024 — classified as 4 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Defective Device” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available4
- Defective Device2
- Infusion or Flow Problem1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient2
- Awareness During Anesthesia1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT THE DEVICE WAS NOT MIXING WELL. THERE WAS UNKNOWN PATIENT INVOLVEMENT BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20261379 ↗MalfunctionSep 20, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS INCOMPLETE SPINAL ANESTHETIZATION DURING THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.
Patient problems: Awareness During Anesthesia
MAUDE report 15454499 ↗InjuryFeb 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
INFORMATION WAS RECEIVED INDICATING THAT THE BUPIVICAIN TO A SMITHS MEDICAL PORTEX® SINGLE SHOT EPIDURAL TRAY FAILED TO WORK AND THE PATIENT WAS CONVERTED TO GENERAL ANESTHESIA. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8323738 ↗InjuryFeb 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
INFORMATION WAS RECEIVED INDICATING THAT THE BUPIVICAINE TO A SMITHS MEDICAL PORTEX® SINGLE SHOT EPIDURAL TRAY FAILED TO WORK AND THE PATIENT WAS CONVERTED TO GENERAL ANESTHESIA. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8323736 ↗InjuryFeb 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
INFORMATION WAS RECEIVED INDICATING THAT THE BUPIVICAINE TO A SMITHS MEDICAL PORTEX® SINGLE SHOT EPIDURAL TRAY FAILED TO WORK AND THE PATIENT WAS CONVERTED TO GENERAL ANESTHESIA. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8323731 ↗InjuryFeb 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
INFORMATION WAS RECEIVED INDICATING THAT THE BUPIVICAINE TO A SMITHS MEDICAL PORTEX® SINGLE SHOT EPIDURAL TRAY FAILED TO WORK AND THE PATIENT WAS CONVERTED TO GENERAL ANESTHESIA. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8323722 ↗MalfunctionJan 30, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A PORTEX® SPINAL KIT DID NOT WORK ON THE PATIENT. IT IS BELIEVED THE DRUG CONTAINED IN THE KIT WAS "WEAK". NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7228882 ↗MalfunctionJan 30, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A PORTEX® SPINAL KIT DID NOT WORK ON THE PATIENT. IT IS BELIEVED THE DRUG CONTAINED IN THE KIT WAS "WEAK". NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7228877 ↗
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-0243-06 · Nov 17, 2005 · Terminated4903 Glass L.O.R. Syringe
- Z-0242-06 · Nov 17, 2005 · Terminated4902 Glass L.O.R. Syringe
- Z-0245-06 · Nov 17, 2005 · Terminated4950-16 Portex Epidural Mini-pack
- 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page