Pro-PICC® CT MR17036302Recalls & reported problems
Medical Components, Inc. · 6F X 60CM TRIPLE LUMEN PRO-PICC® CT BASIC LONG WIRE 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 00884908033465), received between Jul 7, 2020 and Jul 7, 2020 — 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.
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2020Leak/Splash; Leak/Splash
A LEAK WAS DETECTED UNDER THE HUB PORTION OF THE DEVICE OUTSIDE THE INSERTION SITE. UPON REMOVAL IT WAS NOTED THAT THE LUMEN WAS WRINKLED AND LEAKED. DOCTOR SAID "IT MIGHT BE NURSE FREQUENTLY FLUSHED HEPARIN LOCKED QUITE HARD".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10239196 ↗MalfunctionJul 7, 2020Leak/Splash; Leak/Splash
AFTER THE DEVICE WAS REMOVED IT WAS NOTED THAT THE LUMEN WAS WRINKLED AND LEAKED. ISSUE WAS NOTICED OUTSIDE THE PATIENT'S BODY. DOCTOR SAID "IT MIGHT BE NURSE FREQUENTLY FLUSHED HEPARIN LOCKED QUITE HARD".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10239067 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.