Long Term CVC MR28010921Recalls & reported problems
Medical Components, Inc. · 9.5F 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 00884908084290), received between Aug 28, 2023 and Aug 28, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2023Break; Break
RED LUMEN USED FOR BLOODWORK. AFTER BLOODWORK COMPLETED, WRITER FLUSHED LINE W/ NORMAL SALINE SYRINGES & THE LINE APPEARED TO EXPLODE, SPRAYING SALINE OUT. CLARIFICATION PROVIDED INDICATES THE LUER CAME OUT OF THE ARTERIAL EXTENSION TUBING. WRITER IMMEDIATELY CLAMPED & INSPECTED LINE - NO HOLE/PERFORATION; PART OF LINE ATTACHED TO NEEDLELESS CONNECTOR HAD BECOME DISCONNECTED & WAS STILL ATTACHED TO FLUSH. PART IN QUESTION APPEARS TO BE INTACT. PATIENT FINE, WRITER EXPLAINED WHAT HAPPENED, CHARGE NURSE NOTIFIED. RED LUMEN CLAMPED W/ DEVICE CLAMP & KELLY CLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17631497 ↗
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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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