Midline Catheter Kit S4153108BDRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741153983), received between Mar 25, 2020 and Jul 10, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY MEDWATCH THAT MIDLINE PLACED IN R UPPER ARM, LINE MALFUNCTIONED AND IV CONSULT PLACED. ASSESSMENT CONFIRMED, LINE NOT WORKING AND UNABLE TO USE. DID NOTE KINK AT HUB. LINE REMOVED, TWO KINKS NOTED AT HUB AND AT 5CM, ALSO NOTED FIBRIN BUILDUP AT DISTAL END OF LINE. PER MANUFACTURER'S INSTRUCTION, LINES CAN REMAIN IN PLACE FOR 29 DAYS. THE PATIENT REQUIRED ADDITIONAL STICKS FOR PIV THERAPIES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711907 ↗
• MalfunctionMay 20, 2024Material Deformation; Material Deformation

  IT WAS REPORTED ISSUE WITH 3 FR INTRODUCER UPON INSERTION. FROM PLACER "I SAVED BECAUSE IT FELT FUNNY PUSHING IT THROUGH THE TISSUE, AND WHEN I BROKE THE GRAY PART IT LOOKED FRAYED¿. THE EVENT DID NOT INVOLVE AN URGENT SITUATION, THE WIRE DID NOT BREAK OR RETAIN IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355261 ↗
• MalfunctionMay 14, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED "WE HAD AN INTRODUCER ON ONE OF THE MIDLINES NOT WORK PROPERLY. ONE OF THE WINGS OR TOP PIECES THAT YOU BREAK AWAY WITH BROKE OFF SO UNABLE TO TEAR AWAY THE DILATOR." 05/04/2020- ADDITIONAL INFORMATION RECEIVED STATED, "PLACEMENT INFO: UNABLE TO TEAR AWAY DILATOR. ONE OF THE TOP PIECES BROKE OFF WHILE TRYING TO BREAK AWAY. HAD TO REMOVE DILATOR AND USE A DIFFERENT ONE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10057541 ↗
• MalfunctionMar 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH "WHEN VAT NURSE INSERTING THE TRANSDUCER IT WOULD NOT ADVANCE. ENDED UP HAVING TO USE ANOTHER ONE BECAUSE OF IT NOT ADVANCING. WHEN IT WAS PULLED OUT, WE NOTICED THE TIP HAD THREE ROUND RINGS ON IT. IT LOOKS LIKE THE PRODUCT WHEN MANUFACTURED WAS CAUGHT UP SO, IT MADE IT HAVE THE RINGS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9878945 ↗