Portex A1368-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20351688037012), received between May 11, 2018 and May 11, 2018 — classified as 4 malfunctions.

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

• 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 INCID.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507957 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT EITHER THE BUPIVACAINE OR LIDOCAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY FAILED TO DELIVER THE APPROPRIATE NUMBNESS FOLLOWING SPINAL ADMINISTRATION TO THE PATIENT. INFORMATION CONCERNING WHICH OF THE AFOREMENTIONED DRUGS CONTRIBUTED TO THE INCIDENT COULD NOT BE DETERMINED. THE PATIENT UNDERWENT GENERAL ANESTHESIA AS A RESULT OF THE INCIDENT. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THE INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507943 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT EITHER THE BUPIVACAINE OR LIDOCAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY FAILED TO DELIVER THE APPROPRIATE NUMBNESS FOLLOWING SPINAL ADMINISTRATION TO THE PATIENT. INFORMATION CONCERNING WHICH OF THE AFOREMENTIONED DRUGS CONTRIBUTED TO THE INCIDENT COULD NOT BE DETERMINED. THE PATIENT DID NOT UNDERGO GENERAL ANESTHESIA AS A RESULT OF THE INCIDENT. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THE INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507941 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT EITHER THE BUPIVACAINE OR LIDOCAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY FAILED TO DELIVER THE APPROPRIATE NUMBNESS FOLLOWING SPINAL ADMINISTRATION TO THE PATIENT. INFORMATION CONCERNING WHICH OF THE AFOREMENTIONED DRUGS CONTRIBUTED TO THE INCIDENT COULD NOT BE DETERMINED. THE PATIENT UNDERWENT GENERAL ANESTHESIA AS A RESULT OF THE INCIDENT. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THE INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507749 ↗

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-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-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