Portex A4014-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20351688080094), received between May 11, 2018 and May 11, 2018 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Defective Device” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 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. THERE WAS NO SENSORY, MOTOR OR SYMPATHETIC BLOCK. THE PATIENT WAS PLACED UNDER 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 7508286 ↗
• 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 7508029 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT THE BUPIVACAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY WAS INEFFECTIVE. AS A RESULT OF THIS, THE PATIENT WAS PLACED ON GENERAL ANESTHESIA. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508028 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT THE BUPIVACAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY WAS INEFFECTIVE AFTER 17 MINUTES. THE PROCEDURE WAS REPEATED AND WAS SUCCESSFUL AT THE T9 LEVEL. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508025 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT THE BUPIVACAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY WAS INEFFECTIVE. NO MOTOR BLOCK WAS ACHIEVED. AS A RESULT OF THIS, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508023 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT THE BUPIVACAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY WAS INEFFECTIVE. IT WAS ALSO NOTED THAT MOTOR BLOCK WAS NOT ACHIEVED. THERE WAS FULL SENSATION ON THE ANTERIOR KNEE, BUT NO SENSATION ON THE POSTERIOR KNEE. AS A RESULT OF THIS INCIDENT, THE PATIENT WAS PLACED ON GENERAL ANESTHESIA. THERE WERE NO COMPLICATIONS ASSOCIATED WITH THE PLACEMENT. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508022 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT THE BUPIVACAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY WAS INEFFECTIVE. THE SENSORY BLOCK WAS THERE THROUGHOUT THE CASE, BUT THE MOTOR BLOCK ONLY LASTED FOR ONE HOUR. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507759 ↗

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-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-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