Portex 4917M-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00351688047574), received between May 11, 2018 and Aug 27, 2024 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Output Problem” (10 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN THE CATHETER WAS REMOVED, BLACK COLOR WAS NOTED UNDER THE DRESSING. WHEN THE CATHETER WAS PULLED, IT WAS FURTHER NOTED THAT THE CM MARKINGS HAD ¿RUBBED OFF¿ THE CATHETER AND WERE NO LONGER VISIBLE ON THE CATHETER BUT ON THE SKIN AND MAYBE IN THE PATIENT ALONG THE TRACT. THERE WAS PATIENT INVOLVEMENT, AND UNKNOW PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20081157 ↗
• MalfunctionAug 29, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER DISCONNECTED FROM THE EPIDURAL CATHETER DURING LABOR. FEW OTHER INSTANCES THE CATHETER APPEARED TO HAVE A HOLE ALLOWING INFUSION SOLUTION TO LEAK. ONE RECENT WHERE THE CATHETER BROKE OFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316102 ↗
• MalfunctionAug 29, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT CATHETER DISCONNECTED FROM THE EPIDURAL CATHETER DURING LABOR. FEW OTHER INSTANCES THE CATHETER APPEARED TO HAVE A HOLE ALLOWING INFUSION SOLUTION TO LEAK. ONE RECENT WHERE THE CATHETER BROKE OFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15315919 ↗
• MalfunctionAug 29, 2022Break; Fluid/Blood Leak; Material Puncture/Hole; Break; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER DISCONNECTED FROM THE EPIDURAL CATHETER DURING LABOR, CATHETER HAD A HOLE ALLOWING INFUSION SOLUTION TO LEAK, AND CATHETER BROKE OFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15315664 ↗
• MalfunctionAug 29, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT CATHETER DISCONNECTED FROM THE EPIDURAL CATHETER DURING LABOR. FEW OTHER INSTANCES THE CATHETER APPEARED TO HAVE A HOLE ALLOWING INFUSION SOLUTION TO LEAK. ONE RECENT WHERE THE CATHETER BROKE OFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15315302 ↗
• InjuryApr 4, 2021Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A SMITHS MEDICAL CATHETER BROKE OFF WHILE INSERTED IN THE PATIENT. WHEN THE ANESTHESIOLOGIST WENT TO REMOVE THE CATHETER AND REPOSITION IT, THE TIP WAS DISCONNECTED. CT SCAN WAS PERFORMED AND CONFIRMED IT REMAINED INSIDE OF PATIENTS BACK. PATIENT CURRENTLY HAS NO NEUROLOGIC SYMPTOMS AND NEUROSURGERY WAS CONSULTED AND RECOMMENDED NO CURRENT NEED FOR SURGICAL INTERVENTION. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY. THE PATIENT WAS DISCHARGED STABLE, AND ANESTHESIA WILL CONTINUE TO FOLLOW UP WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611915 ↗
• MalfunctionFeb 26, 2020Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX® EPIDURAL CATHETER BECAME DISCONNECTED FROM THE DURAFLEX CATHETER. A HOLE WAS REPORTED IN WHICH THE INFUSION LEAKED. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9753982 ↗
• MalfunctionFeb 26, 2020Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX® EPIDURAL CATHETER BECAME DISCONNECTED FROM THE DURAFLEX CATHETER. A HOLE WAS REPORTED IN WHICH THE INFUSION LEAKED. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9753980 ↗
• MalfunctionOct 2, 2019Output Problem; Output Problem

  THE REPORTER STATED THE USER ATTEMPTED TO INSERT THE CATHETER IN PATIENT EPIDURAL SPACE BUT THE CATHETER WAS "STIFF" AND THIS ISSUE CAUSED THE USER TO "HIT VASCULAR VESSELS" WHICH CAUSED BLEEDING. THE PROCEDURE WAS NOT COMPLETED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: Blood Loss

  MAUDE report 9145295 ↗
• MalfunctionAug 19, 2019Output Problem; Output Problem

  THE REPORTER STATED THE USER ATTEMPTED TO INSERT THE CATHETER IN PATIENT EPIDURAL SPACE BUT THE CATHETER WAS "STIFF" AND THIS ISSUE CAUSED THE USER TO "HIT VASCULAR VESSELS" WHICH CAUSED BLEEDING. THE PROCEDURE WAS NOT COMPLETED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8906417 ↗
• MalfunctionJun 21, 2019Output Problem; Output Problem

  THE REPORTER STATED THE USER ATTEMPTED TO INSERT THE CATHETER IN PATIENT EPIDURAL SPACE BUT THE CATHETER WAS "STIFF" AND THIS ISSUE CAUSED THE USER TO "HIT VASCULAR VESSELS" WHICH CAUSED BLEEDING. THE PROCEDURE WAS NOT COMPLETED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8722823 ↗
• MalfunctionJun 21, 2019Output Problem; Output Problem

  THE REPORTER STATED THE USER ATTEMPTED TO INSERT THE CATHETER IN PATIENT EPIDURAL SPACE BUT THE CATHETER WAS "STIFF" AND THIS ISSUE CAUSED THE USER TO "HIT VASCULAR VESSELS" WHICH CAUSED BLEEDING. THE PROCEDURE WAS NOT COMPLETED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8722487 ↗
• MalfunctionJun 20, 2019Output Problem; Output Problem

  THE REPORTER STATED THE USER ATTEMPTED TO INSERT THE CATHETER IN PATIENT EPIDURAL SPACE BUT THE CATHETER WAS "STIFF" AND THIS ISSUE CAUSED THE USER TO "HIT VASCULAR VESSELS" WHICH CAUSED BLEEDING. THE PROCEDURE WAS NOT COMPLETED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8718432 ↗
• MalfunctionJun 20, 2019Output Problem; Output Problem

  THE REPORTER STATED THE USER ATTEMPTED TO INSERT THE CATHETER IN PATIENT EPIDURAL SPACE BUT THE CATHETER WAS "STIFF" AND THIS ISSUE CAUSED THE USER TO "HIT VASCULAR VESSELS" WHICH CAUSED BLEEDING. THE PROCEDURE WAS NOT COMPLETED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8718431 ↗
• MalfunctionJun 20, 2019Output Problem; Output Problem

  THE REPORTER STATED THE USER ATTEMPTED TO INSERT THE CATHETER IN PATIENT EPIDURAL SPACE BUT THE CATHETER WAS "STIFF" AND THIS ISSUE CAUSED THE USER TO "HIT VASCULAR VESSELS" WHICH CAUSED BLEEDING. THE PROCEDURE WAS NOT COMPLETED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8718430 ↗
• MalfunctionJun 20, 2019Output Problem; Output Problem

  THE REPORTER STATED THE USER ATTEMPTED TO INSERT THE CATHETER IN PATIENT EPIDURAL SPACE BUT THE CATHETER WAS "STIFF" AND THIS ISSUE CAUSED THE USER TO "HIT VASCULAR VESSELS" WHICH CAUSED BLEEDING. THE PROCEDURE WAS NOT COMPLETED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8718429 ↗
• MalfunctionJun 20, 2019Output Problem; Output Problem

  THE REPORTER STATED THE USER ATTEMPTED TO INSERT THE CATHETER IN PATIENT EPIDURAL SPACE BUT THE CATHETER WAS "STIFF" AND THIS ISSUE CAUSED THE USER TO "HIT VASCULAR VESSELS" WHICH CAUSED BLEEDING. THE PROCEDURE WAS NOT COMPLETED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8718428 ↗
• MalfunctionJun 20, 2019Output Problem; Output Problem

  THE REPORTER STATED THE USER ATTEMPTED TO INSERT THE CATHETER IN PATIENT EPIDURAL SPACE BUT THE CATHETER WAS "STIFF" AND THIS ISSUE CAUSED THE USER TO "HIT VASCULAR VESSELS" WHICH CAUSED BLEEDING. THE PROCEDURE WAS NOT COMPLETED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: Blood Loss

  MAUDE report 8718425 ↗
• MalfunctionMay 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT FELT A WET SPOT ON BACK. WHEN THE NURSING STAFF ASSESSED, THEY SAW THE TIP OF THE CATHETER THAT CONNECTS TO THE IV LINE HAD DISCONNECTED FROM THE CATHETER LINE, AND FLUID WAS LEAKING OUT AS A RESULT. BROKEN CATHETER HAD TO BE REMOVED, NEW EPIDURAL CATHETER HAD TO BE INSERTED. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507711 ↗