Long Term CVC MR28010911Recalls & reported problems
Medical Components, Inc. · 9.5F X 90CM SINGLE LUMEN LT CVC BASIC KIT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00884908084276), received between Dec 4, 2019 and Dec 19, 2019 — 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
- Blood Loss1
- 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 19, 2019Leak/Splash; Leak/Splash
FACILITY REPORTED PATIENT WAS SEEN IN INTERVENTIONAL RADIOLOGY FOR LOW FLOW VASCULAR CATHETER EXCHANGE. THE SINGLE LUMEN CATHETER NEEDED TO BE REPLACED DUE TO A CRACK WITHIN IT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9495261 ↗MalfunctionDec 4, 2019Leak/Splash; Leak/Splash
PATIENT UNDERWENT EPOPROSTENOL INFUSION THROUGH THE SINGLE LUMEN CVC CATHETER. PATIENT LATER SUMMONED THE NURSE WHO FOUND THE PATIENT HAD BLOOD SOAKING THROUGH HER GOWN. THE NURSE FURTHER INVESTIGATED TO FIND A CRACK IN THE CVC CATHETER NEAR THE SITE OF INSERTION AND SUTURING. EPOPROSTENOL WAS TRANSFERRED TO AN OPEN PERIPHERAL LINE. PATIENT WAS TAKEN FOR EMERGENT REPLACEMENT OF THE CVC CATHETER.
Patient problems: Blood Loss
MAUDE report 9413111 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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