Long Term CVC MR28011121Recalls & reported problems
Medical Components, Inc. · 11F X 90CM DOUBLE LUMEN LT CVC BASIC KIT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908084306), received between May 13, 2020 and May 13, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
Device problems
- Leak/Splash1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2020Leak/Splash; Leak/Splash
THE CVC WAS BEING FLUSHED. THE CATHETER HAD VANCOMYCIN INSTILLED AND 2MLS WAS WITHDRAWN. WHEN 10MLS OF NS WAS FLUSHED THE CATHETER BROKE AND SALINE SQUIRTED OUT. APPLIED A HEMOSTAT TO THE CATHETER LINE TO PREVENT FURTHER LEAKS. THE PATIENT REQUIRED CATHETER REPLACEMENT. USER FACILITY SUBMITTED MEDWATCH (B)(4) FOR THIS EVENT.
Patient problems: Blood Loss
MAUDE report 10051217 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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