Portex A3169-17/27Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517142693), received between Feb 7, 2019 and Mar 20, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Flush” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2019Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED THAT THE EPIDURAL FROM A SMITHS MEDICAL PORTEX COMBINED SPINAL EPIDURAL CUSTOM TRAY "WAS UNEVENTFUL, WHICH RESULTED IN AN INTRATHECAL CATHETER". THE REPORTER ALSO STATED THE ISSUE WAS "RECOGNIZED AND THE PATIENT WAS TAKEN INTO THE OPERATING ROOM EMERGENTLY AND WAS ABLE TO DELIVER VAGINALLY". NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8438244 ↗
• MalfunctionFeb 7, 2019Difficult to Flush; Leak/Splash; Material Puncture/Hole; Difficult to Flush; Leak/Splash; Material Puncture/Hole

  INFORMATION WAS RECEIVED INDICATING THAT THE CATHETER TO A SMITHS MEDICAL PORTEX SPINAL EPIDURAL CUSTOM TRAY WAS NOTED TO HAVE A HOLE ABOUT 6 INCHES PROXIMAL TO THE CONNECTOR. THE CLINICIAN HAD BEEN CALLED TO THE PATIENT'S BEDSIDE TO GIVE A BOLUS WHEN THE HOLE WAS FOUND AND THAT IT HAD LEAKED ONTO THE PATIENT'S BED. THE CLINICIAN HAD STATED THAT EARLIER THAT DAY, THE CATHETER WAS UNABLE TO BE FLUSHED THROUGH THE YELLOW CONNECTOR. THE YELLOW CONNECTOR WAS REOPENED AND THEN SUCCESSFULLY FLUSHED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8319078 ↗

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