Pro-Line® CT MR28035101Recalls & reported problems
Medical Components, Inc. · 5F X 60CM SINGLE LUMEN Pro-Line® CT BASIC IR SET · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908034608), received between Nov 5, 2019 and Dec 13, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2023Leak/Splash; Leak/Splash
LOSS OF SALINE SOLUTION FROM THE HUB WAS NOTED DURING USE AT BOTH CATHETER LUMENS. THERE IS NO LOSS FROM THE HUB WITH NFC CONNECTED TO THE CATHETER. DEVICE USED FOR DRUG INFUSION AND PARENTERAL NUTRITION. EVENT OCCURRED ON THE FIRST USE. DEVICE WAS REMOVED AND A NEW DEVICE IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18319642 ↗MalfunctionNov 5, 2019Leak/Splash; Leak/Splash
DURING CT INJECTION WITH THE 5F PRO-LINE, A LEAK WAS DETECTED AT THE JUNCTION OF THE LUER AND EXTENSION TUBING. NO ADVERSE CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9278624 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.