Portex NEPI-49661C-25Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517115505), received between Jul 25, 2018 and Jul 25, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Output Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Output Problem4
Patient problems
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2018Output Problem; Output Problem
INFORMATION WAS RECEIVED THAT THE BUPIVACAINE IN SMITHS MEDICAL SPINAL SINGLE SHOT TRAY WAS INEFFECTIVE. IT WAS REPORTED TO NOT BE ANESTHETIZING THE PATIENT AND AS A RESULT, HAVE HAD TO PUT THE PATIENT TO SLEEP FOR PROCEDURE. NO PATIENT INJURY RESULTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7720198 ↗MalfunctionJul 25, 2018Output Problem; Output Problem
INFORMATION WAS RECEIVED THAT THE BUPIVACAINE IN SMITHS MEDICAL SPINAL SINGLE SHOT TRAY WAS INEFFECTIVE. IT WAS REPORTED TO NOT BE ANESTHETIZING THE PATIENT AND AS A RESULT, HAVE HAD TO PUT THE PATIENT TO SLEEP. NO PATIENT INJURY RESULTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7720175 ↗MalfunctionJul 25, 2018Output Problem; Output Problem
INFORMATION WAS RECEIVED THAT THE BUPIVACAINE IN SMITHS MEDICAL SPINAL SINGLE SHOT TRAY WAS INEFFECTIVE. IT WAS REPORTED TO NOT BE ANESTHETIZING THE PATIENT AND AS A RESULT, HAVE HAD TO PUT THE PATIENT TO SLEEP FOR PROCEDURE. NO PATIENT INJURY RESULTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7720174 ↗MalfunctionJul 25, 2018Output Problem; Output Problem
INFORMATION WAS RECEIVED THAT THE BUPIVACAINE IN SMITHS MEDICAL SPINAL SINGLE SHOT TRAY WAS INEFFECTIVE. IT WAS REPORTED TO NOT BE ANESTHETIZING THE PATIENT AND AS A RESULT, HAVE HAD TO PUT THE PATIENT TO SLEEP FOR PROCEDURE. NO PATIENT INJURY RESULTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7720172 ↗
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-0244-06 · Nov 17, 2005 · Terminated4904 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-0243-06 · Nov 17, 2005 · Terminated4903 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.
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