Portex NEPI-NLD-15583C-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517115680), received between Dec 14, 2017 and Sep 24, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Medication Error” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024Application Program Problem: Medication Error; Application Program Problem: Medication Error

  IT WAS REPORTED THAT A SPINAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT AND THE SPINAL WAS DONE UNEVENTFULLY HOWEVER THE MEDICATION DID NOT PERFORM AS IT SHOULD HAVE. NO ANESTHETIC LEVEL WAS ACHIEVED, AND THE PATIENT HAD TO GO UNDER GENERAL ANESTHESIA. THERE WAS PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291674 ↗
• MalfunctionMar 24, 2019Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED THAT THE BUPIVICAINE IN A SMITHS MEDICAL PORTEX SPINAL ANESTHESIA TRAY DID NOT WORK DURING A PROCEDURE. IT WAS NOTED THAT THE "PATIENT DIDN'T HAVE ANY COMPLICATION AND DIDN'T HAVE ANY ANATOMICAL ISSUE THAT LEAD TO SPINAL INSERTION COMPLICATION. DUE TO COMPLICATIONS FROM THE KIT NOT WORKING, THE PATIENT WAS FORCED TO RECEIVE GENERAL ANESTHESIA".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8446738 ↗
• MalfunctionDec 20, 2017Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT A PATIENT WAS NOT RECEIVING RELIEF WITH TH USE OF A PORTEX® SPINAL ANESTHESIA TRAY. THE PATIENT REQUIRED EXTRA PAIN MEDICATIONS. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS OCCURRENCE.

  Patient problems: Pain

  MAUDE report 7135840 ↗
• MalfunctionDec 14, 2017Defective Component; Defective Component

  IT WAS REPORTED THAT A PORTEX® SPINAL ANESTHESIA TRAY WAS NOT EFFECTIVE. THE PATIENT REPORTED NO RELIEF. THE PATIENT WAS GIVEN INTRAVENOUS CENTENOL IN ORDER TO ALLEVIATE PAIN. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Pain

  MAUDE report 7117936 ↗

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-0244-06 · Nov 17, 2005 · Terminated
  4904 Glass L.O.R. Syringe
• Z-0242-06 · Nov 17, 2005 · Terminated
  4902 Glass L.O.R. Syringe
• Z-0243-06 · Nov 17, 2005 · Terminated
  4903 Glass L.O.R. Syringe
• Z-0245-06 · Nov 17, 2005 · Terminated
  4950-16 Portex Epidural Mini-pack
• 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