Midline Catheter Kit P4254108Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741129278), received between Mar 1, 2018 and May 2, 2023 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Or Device Fragments Location Unknown” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2663-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE MIDLINE WAS PLACED WITH NO INCIDENT, MIDLINE PROVIDED GOOD BLOOD RETURN WHEN ASSESSED BUT THEN WHEN FLUSHED BEGAN TO SPRAY SALINE AROUND THE SUTURE WINGS WHERE THEY MET THE CATHETER. MIDLINE WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16856094 ↗
• InjuryMar 29, 2018Air Leak; Fluid/Blood Leak; Device Or Device Fragments Location Unknown

  THE POWER MIDLINE CATHETER WAS REMOVED DUE TO A REPORTED LEAK OF FLUID AND AIR. ONCE THE CATHETER WAS REMOVED IT WAS REPORTED THAT 15CM OF THE CATHETER'S DISTAL END WAS MISSING. IT WAS REPORTED THAT ONLY 6.5CM REMAINED CONNECTED TO THE HUB.

  Patient problems: No Code Available

  MAUDE report 7383952 ↗
• DeathMar 1, 2018Leak/Splash; Device Or Device Fragments Location Unknown

  IT WAS REPORTED THAT A NURSE PLACED A POWERMIDLINE IN A PATIENT ON (B)(6)2018 THAT WAS CUT TO 15CM PRIOR TO INSERTION. ON (B)(6) 2018 THE PATIENT HAD A CHEST X-RAY WHICH SHOWED AN INTACT CATHETER. ON (B)(6) 2018 THE PATIENT HAD ANOTHER CHEST X-RAY AND THE CATHETER WAS NOT SEEN. THE CATHETER BEGAN LEAKING AND ON (B)(6) 2018 THE SAME NURSE THAT PLACED THE CATHETER PERFORMED AN OVER THE WIRE TRANSFER TO REPLACE IT. ONCE REMOVED, THE CATHETER WAS NOTED TO ONLY BE 5 1/2 CM IN LENGTH FROM THE ZERO MARK. X-RAYS, CT SCANS AND FLUOROSCOPY WERE PERFORMED TO LOCATE THE BROKEN PIECE OF CATHETER, HOWEVER, IT WAS NOT FOUND IN THE PATIENT. IT WAS NOTED THAT THE TIP OF THE REMOVED PIECE OF CATHETER IS SMOOTH AND AT AN ANGLE. IT WAS ALSO REPORTED THAT THE PATIENT EXPIRED (B)(6) 2018 DUE TO TERMINAL WEAN OFF OF A VENTILATOR.

  Patient problems: Death; Device Embedded In Tissue or Plaque

  MAUDE report 7308224 ↗