Midline Catheter Kit S4153108DGRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741153969), received between Mar 19, 2020 and Oct 18, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER, THE GREEN SAFETY SLID OFF THE INTRODUCER NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482319 ↗
• MalfunctionSep 11, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THERE WAS AN INCIDENT WITH THE GREEN NEEDLE THIS MORNING. THE SAFETY SLID RIGHT OFF WHEN I WENT TO CAP IT OFF. NO HARM TO PATIENT OR USER. WAS ABLE TO DISPOSE OF SHARP SAFELY WITHOUT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20197133 ↗
• MalfunctionMay 13, 2022Material Deformation; Material Deformation

  IT WAS REPORTED "MICROINTRODUCER OF 3FR PROVENA MIDLINE KIT BUCKLED AND FAILED DURING INSERTION." (B)(6) 2022- THE DILATOR AND SHEATH IN THE RETURNED PHOTO APPEARED TO BE BENT NEAR THE DISTAL END. THE SHEATH MATERIAL WAS BUCKLED/BALLOONED DIRECTLY PROXIMAL OF THE BENT REGION ON THE MICROINTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14397579 ↗
• MalfunctionNov 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT PROVENA MIDLINE CATHETER WAS REMOVED IN LESS THAN 3 DAYS AFTER INSERTION DUE TO MALFUNCTIONING. UPON REMOVAL, THE CATHETER WAS CURVED WHICH CONFIRMED LINE FUNCTION ISSUE BASED ON THE PATIENTS ARM POSITION. THE LINE WAS IN AN INTENSIVE CARE PATIENT. (B)(6) 2020: EVALUATION FOUND THE CATHETER WAS KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10846433 ↗
• MalfunctionNov 16, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT PROVENA MIDLINE CATHETER WAS REMOVED IN LESS THAN 3 DAYS AFTER INSERTION DUE TO MALFUNCTIONING. UPON REMOVAL, THE CATHETER WAS CURVED WHICH CONFIRMED LINE FUNCTION ISSUE BASED ON THE PATIENTS ARM POSITION. ON (B)(6) 2020 THE RETURNED CATHETER WAS KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10846424 ↗
• MalfunctionMar 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT HAD 3 FR PLACED IN THE LEFT BASILIC VEIN AND TRIMMED AT 11 CM. THE INITIAL ISSUE WAS NOT REPORTED, BUT THE EVENT OCCURRED AT HOME. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 02/27/2020 - INFILTRATED LINE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857599 ↗