Portex NEPI-NLD-15597C-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 15019517115710), received between May 15, 2018 and Jun 27, 2018 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2018Material Fragmentation; Device Contamination with Chemical or Other Material

  ABOVE PATIENT WAS SCHEDULED TO UNDERGO A CESAREAN SECTION. PRIOR TO SPINAL INJECTION FOR SPINAL BLOCK, A PARTICULATE, WHICH APPEARED TO BE PLASTIC, WAS NOTED IN THE BARREL OF THE SYRINGE. THE SYRINGE WAS NOT USED ON THE PATIENT.

  Patient problems: No Information

  MAUDE report 7645559 ↗
• MalfunctionMay 15, 2018Failure to Deliver; Failure to Deliver

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING USE OF A SMITHS MEDICAL PORTEX® SPINAL ANESTHESIA TRAY THE PATIENT HAD DIMINISHED SENSATION AND MOTOR WEAKNESS; STILL FEELING AND MOVING LEGS. SUBSEQUENTLY, THE PATIENT WAS REQUIRED TO GO UNDER GENERAL ANESTHESIA FOR THE SURGICAL PROCEDURE. THERE WAS NO REPORTED ADVERSE EFFECTS.

  Patient problems: Numbness; Weakness

  MAUDE report 7514101 ↗
• MalfunctionMay 15, 2018Failure to Deliver; Failure to Deliver

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING USE OF A SMITHS MEDICAL PORTEX® SPINAL ANESTHESIA TRAY THE PATIENT HAD DIMINISHED SENSATION AND MOTOR WEAKNESS; STILL FEELING AND MOVING LEGS. SUBSEQUENTLY, THE PATIENT WAS REQUIRED TO GO UNDER GENERAL ANESTHESIA FOR THE SURGICAL PROCEDURE. THERE WAS NO REPORTED ADVERSE EFFECTS.

  Patient problems: Numbness; Weakness

  MAUDE report 7514100 ↗
• MalfunctionMay 15, 2018Failure to Deliver; Failure to Deliver

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING USE OF A SMITHS MEDICAL PORTEX® SPINAL ANESTHESIA TRAY THE PATIENT HAD DIMINISHED SENSATION AND MOTOR WEAKNESS; STILL FEELING AND MOVING LEGS. SUBSEQUENTLY, THE PATIENT WAS REQUIRED TO GO UNDER GENERAL ANESTHESIA FOR THE SURGICAL PROCEDURE. THERE WAS NO REPORTED ADVERSE EFFECTS.

  Patient problems: Numbness; Weakness

  MAUDE report 7514099 ↗
• MalfunctionMay 15, 2018Failure to Deliver; Failure to Deliver

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING USE OF A SMITHS MEDICAL PORTEX® SPINAL ANESTHESIA TRAY THE PATIENT HAD DIMINISHED SENSATION AND MOTOR WEAKNESS; STILL FEELING AND MOVING LEGS. SUBSEQUENTLY, THE PATIENT WAS REQUIRED TO GO UNDER GENERAL ANESTHESIA FOR THE SURGICAL PROCEDURE. THERE WAS NO REPORTED ADVERSE EFFECTS.

  Patient problems: Numbness; Weakness

  MAUDE report 7514096 ↗
• MalfunctionMay 15, 2018Failure to Deliver; Failure to Deliver

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING USE OF A SMITHS MEDICAL PORTEX® SPINAL ANESTHESIA TRAY THE PATIENT HAD DIMINISHED SENSATION AND MOTOR WEAKNESS; STILL FEELING AND MOVING LEGS. SUBSEQUENTLY, THE PATIENT WAS REQUIRED TO GO UNDER GENERAL ANESTHESIA FOR THE SURGICAL PROCEDURE. THERE WAS NO REPORTED ADVERSE EFFECTS.

  Patient problems: Numbness; Weakness

  MAUDE report 7514094 ↗
• MalfunctionMay 15, 2018Failure to Deliver; Failure to Deliver

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING USE OF A SMITHS MEDICAL PORTEX® SPINAL ANESTHESIA TRAY THE PATIENT HAD DIMINISHED SENSATION AND MOTOR WEAKNESS; STILL FEELING AND MOVING LEGS. SUBSEQUENTLY, THE PATIENT WAS REQUIRED TO GO UNDER GENERAL ANESTHESIA FOR THE SURGICAL PROCEDURE. THERE WAS NO REPORTED ADVERSE EFFECTS.

  Patient problems: Numbness; Weakness

  MAUDE report 7514092 ↗
• MalfunctionMay 15, 2018Failure to Deliver; Failure to Deliver

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING USE OF A SMITHS MEDICAL PORTEX® SPINAL ANESTHESIA TRAY, THE PATIENT HAD DIMINISHED SENSATION AND MOTOR WEAKNESS; STILL FEELING AND MOVING LEGS. SUBSEQUENTLY, THE PATIENT WAS REQUIRED TO GO UNDER GENERAL ANESTHESIA FOR THE SURGICAL PROCEDURE. THERE WAS NO REPORTED ADVERSE EFFECTS.

  Patient problems: Numbness; Weakness

  MAUDE report 7514090 ↗
• MalfunctionMay 15, 2018Failure to Deliver; Failure to Deliver

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING USE OF A SMITHS MEDICAL PORTEX® SPINAL ANESTHESIA TRAY, THE PATIENT HAD DIMINISHED SENSATION AND MOTOR WEAKNESS; STILL FEELING AND MOVING LEGS. SUBSEQUENTLY, THE PATIENT WAS REQUIRED TO GO UNDER GENERAL ANESTHESIA FOR THE SURGICAL PROCEDURE. THERE WAS NO REPORTED ADVERSE EFFECTS.

  Patient problems: Numbness; Weakness

  MAUDE report 7514086 ↗
• MalfunctionMay 15, 2018Failure to Deliver; Failure to Deliver

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING USE OF A SMITHS MEDICAL PORTEX® SPINAL ANESTHESIA TRAY THE PATIENT HAD DIMINISHED SENSATION AND MOTOR WEAKNESS; STILL FEELING AND MOVING LEGS. SUBSEQUENTLY, THE PATIENT WAS REQUIRED TO GO UNDER GENERAL ANESTHESIA FOR THE SURGICAL PROCEDURE. THERE WAS NO REPORTED ADVERSE EFFECTS.

  Patient problems: Numbness; Weakness

  MAUDE report 7514085 ↗
• MalfunctionMay 15, 2018Failure to Deliver; Failure to Deliver

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING USE OF A SMITHS MEDICAL PORTEX® SPINAL ANESTHESIA TRAY THE PATIENT HAD DIMINISHED SENSATION AND MOTOR WEAKNESS; STILL FEELING AND MOVING LEGS. SUBSEQUENTLY, THE PATIENT WAS REQUIRED TO GO UNDER GENERAL ANESTHESIA FOR THE SURGICAL PROCEDURE. THERE WAS NO REPORTED ADVERSE EFFECTS.

  Patient problems: Numbness; Weakness

  MAUDE report 7514081 ↗

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-0244-06 · Nov 17, 2005 · Terminated
  4904 Glass L.O.R. Syringe
• 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