Portex NEPI-NLD-15545C-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 15019517115611), received between Aug 7, 2018 and Aug 7, 2018 — classified as 20 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (20 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

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759218 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759214 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759211 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759209 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759207 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759198 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759197 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759195 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759191 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759189 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759187 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759185 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759181 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759180 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759179 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759175 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759171 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759168 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759163 ↗
• InjuryAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AT AN ANESTHESIA DEPARTMENT MEETING IT WAS DISCOVERED THAT A PORTEX® SPINAL ANESTHESIA TRAY HAD NOT WORKED AT ALL.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7759162 ↗

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, Classified
  Portex Spinal Tray, Item No. A3729-24 A3595
• Z-0211-2007 · Oct 27, 2006 · Terminated
  Portex Continuous Epidural tray Ref 4948-17
• Z-0245-06 · Nov 17, 2005 · Terminated
  4950-16 Portex Epidural Mini-pack
• Z-0243-06 · Nov 17, 2005 · Terminated
  4903 Glass L.O.R. Syringe
• Z-0242-06 · Nov 17, 2005 · Terminated
  4902 Glass L.O.R. Syringe
• Z-0244-06 · Nov 17, 2005 · Terminated
  4904 Glass L.O.R. Syringe
• Z-0166-04 · Oct 10, 2003 · Terminated
  Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20