Midline Catheter Kit P4255118Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741141010), received between Sep 23, 2022 and Sep 23, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Infuse” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2022Suction Problem; Suction Problem

  IT WAS REPORTED " RESISTANCE TO REMOVAL FOR VENOUS RETURN; NO VENOUS RETURN POSSIBLE. POST EXPLANTATION 2 DAYS OF RIGHT ARM PAIN, EDEMA, REDNESS, REDUCED MOBILITY, NUMBNESS IN FINGERS AND RIGHT HAND. VENOUS DOPPLER SHOWED THROMBOPHLEBITIS, REQUIRES FRAGMENT INJECTIONS OF 3 MONTHS."

  Patient problems: Numbness; Pain; Thrombosis/Thrombus

  MAUDE report 15473280 ↗
• InjurySep 23, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED "PATIENT DEVELOPED THROMBOPHLEBITIS, APPROXIMATELY 15CM PHLEBITIC ZONE ALONG THE BASILIC VEIN. INITIAL MIDLINE WAS OCCLUDED, NO RETURN FLOW, A SECOND MIDLINE WAS INSTALLED, THIS TIME IN THE CEPHALIC VEIN. PATIENT HAS HAD OUTPATIENT TREATMENT FOR THE THROMBOPHLEBITIS. DOPPLER IDENTIFIED THE 15CM THROMBOPHLEBITIS ON (B)(6) 2022."

  Patient problems: Thrombosis/Thrombus; Vasculitis

  MAUDE report 15472713 ↗