Long Term CVC MR28010721Recalls & reported problems
Medical Components, Inc. · 7F 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
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00884908084283), received between Aug 31, 2017 and Oct 4, 2024 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash8
- Difficult to Flush2
- Break1
Patient problems
- No Known Impact Or Consequence To Patient6
- No Clinical Signs, Symptoms or Conditions4
- No Information1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2024Leak/Splash; Leak/Splash
CATHETER RUPTURE (LUMEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20371404 ↗MalfunctionOct 4, 2024Leak/Splash; Leak/Splash
HOLE NEAR THE FIXING AREA (LUMEN). AND WHEN PERFORMING "FLUSHING" IT WAS SQUIRTING THE SOLUTION. THE DEVICE WAS ISOLATED WITHOUT CONDITIONS FOR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20371207 ↗MalfunctionOct 4, 2024Leak/Splash; Leak/Splash
AFTER BLOOD COLLECTION AND DURING 0.9% SALINE FLUSHING, THE DEVICE (LUMEN) FRACTURED/RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20370672 ↗MalfunctionOct 4, 2024Leak/Splash; Leak/Splash
SLOW FLOW IN BOTH WAYS AND NO REFLUX IN THE RED WAY AND WHEN PERFORMING THE "FLUSHING" PROCEDURE WITH SALINE SOLUTION WHEN DEACTIVATING IT, A FRACTURE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20370653 ↗MalfunctionOct 3, 2019Difficult to Flush; Difficult to Flush
THE RED SIDE LUMEN IS UNABLE TO FLUSH AND BALLOONS AT THE JOINT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9150908 ↗MalfunctionSep 23, 2019Break
FACILITY REPORTED THE DOUBLE LUMEN CATHETER BROKE.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 9105998 ↗MalfunctionSep 19, 2019Difficult to Flush; Leak/Splash; Difficult to Flush; Leak/Splash
THE NURSE WAS CHECKING THE ARTERIAL LUMEN OF THE CENTRAL VENOUS CATHETER FOR POSSIBLE USE OF A THROMBOLYTIC DRUG DUE TO OCCLUSION. WHILE FLUSHING THE ARTERIAL LUMEN WITH A 10CC SALINE SYRINGE, THE LUMEN PAST THE "Y" SECTION ERUPTED. THE RUPTURE WAS SEALED WITH A TRANSPARENT POLYURETHANE MEMBRANE (OPSITE) THE CATHETER WAS REPLACED THE FOLLOWING DAY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9086333 ↗MalfunctionAug 31, 2017Leak/Splash; Leak/Splash
BLUE LUMEN LEAKAGE FROM TEAR, JUST BELOW THE HUB. LUMEN WAS NOT USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6834153 ↗MalfunctionAug 31, 2017Leak/Splash; Leak/Splash
BLUE LUMEN LEAKAGE FROM TEAR, JUST BELOW THE HUB. LUMEN WAS NOT USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6834105 ↗MalfunctionAug 31, 2017Leak/Splash; Leak/Splash
BLUE LUMEN LEAKAGE FROM TEAR, JUST BELOW THE HUB. LEAKED IN THE FIRST USAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6834033 ↗
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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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