Portex 49661C-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00351688047116), received between Mar 28, 2017 and May 29, 2018 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Defective Device” (17 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7550677 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508242 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508234 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508232 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508228 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508227 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508223 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508019 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507948 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507920 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507826 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507822 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507820 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507816 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A MARCAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE FOR PAIN BLOCK. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507797 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A MARCAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE FOR PAIN BLOCK. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507785 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT A MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507782 ↗
• MalfunctionDec 6, 2017Degraded; Degraded

  IT WAS ADDITIONALLY REPORTED THAT THE FAULT OCCURRED AFTER 25 MINUTES IN USE. GENERAL ANESTHESIA WAS THEN USED.

  Patient problems: Awareness During Anesthesia

  MAUDE report 7086212 ↗
• InjuryAug 24, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING USE OF THIS PORTEX® SPINAL ANESTHESIA TRAY, A FRAGMENT OF THE NEEDLE HAD BROKEN OFF AND REMAINED BENEATH THE SKIN. INTRAOPERATIVELY, UPON PLACING A SINGLE STICK, THE MEDICAL DOCTOR NO LONGER BELIEVED A NEEDLE WOULD BE NEEDED. SUBSEQUENTLY DURING REMOVAL, A 1.25 INCH PORTION OF THE 25G NEEDLE BROKE OFF HYPODERMICALLY. THE PROCEDURE WAS THEN CARRIED OUT SUCCESSFULLY AND THE PATIENT WAS MONITORED. IT WAS NOTED DURING REMOVAL THAT THE STYLETTE WAS STRAIGHT AND NO DEFORMITIES WERE OBSERVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6816987 ↗
• InjuryMar 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PORTEX® SPINAL ANESTHESIA TRAY WAS USED FOR A CESARIAN SECTION. IT WAS OBSERVED THAT THE USER HAD A "POSITIVE SWIRL" TWO TIMES AND THE PATIENT'S ANESTHESIA LEVEL WAS DEEMED APPROPRIATE FOR THE PROCEDURE. IT WAS NOTED THAT 25MCG OF FENTANYL WAS ADDED TO THE INCLUDED BUPIVACAINE DOSE. WHEN THE USER MADE AN INCISION, THE PATIENT EXPERIENCED INTENSE PAIN AND WAS UNABLE TO LAY STILL FOR THE PROCEDURE. THE PATIENT WAS INTUBATED TO COMPLETE THE PROCEDURE. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Awareness During Anesthesia; Pain

  MAUDE report 6439268 ↗
• InjuryMar 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PORTEX® SPINAL ANESTHESIA TRAY WAS USED FOR INTRATHECAL ANESTHESIA FOR A CESARIAN SECTION WHEN THE PATIENT HAD INADEQUATE ANESTHESIA. IT WAS OBSERVED THAT THE SPINAL NEEDLE HAD CEREBRAL SPINAL FLUID (CSF) FLOW AND 0.75% BUPIVACAINE WAS INJECTED. IT WAS NOTED THAT THERE WAS CSF ASPIRATION AT THE END OF THE INJECTION. THE PATIENT WAS OBSERVED TO HAVE "1-2 LEVELS OF ANESTHESIA" IN THE ABDOMEN AND WAS ABLE TO MOVE HER LOWER EXTREMITIES. THE PATIENT WAS CONVERTED TO GENERAL ANESTHESIA DUE TO THE EVENT. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Awareness During Anesthesia

  MAUDE report 6439263 ↗

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-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-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