Long Term CVC MR28011231Recalls & reported problems
Medical Components, Inc. · 12.5F X 90CM TRIPLE LUMEN LT CVC BASIC KIT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884908084320), received between Nov 21, 2018 and Aug 23, 2022 — classified as 4 malfunctions.
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
- Detachment of Device or Device Component1
- Fracture1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2022Break; Break
IT WAS OBSERVED THAT THE CATHETER WAS LEAKING. WHEN EVALUATED BY THE DOCTOR, RUPTURE OF THE LUMEN WAS EVIDENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15275795 ↗MalfunctionJun 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
BY SALINIZING THE BLUE PATH OF THE HICKMAN CATHETER, THE WHITE PART OF THE EXTENSION TO WHICH THE CLAVE CONNECTOR IS CONNECTED BECAME DISCONNECTED FROM THE REST OF THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14622233 ↗MalfunctionOct 22, 2019Fracture; Fracture
SURGEON REPORTED "FRACTURE ON THE CATHETER PROXIMAL TO THE EXIT SITE".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9221245 ↗MalfunctionNov 21, 2018Separation Problem; Separation Problem
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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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