INFUSION CATHETERS MC2LP-313SRecalls & reported problems
Medical Components, Inc. · 4F X 13CM DOUBLE LUMEN INFUSION CATHETER SET · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884908028331), received between Oct 11, 2017 and Feb 17, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Crack” (3 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.
Most reported problems
Device problems
- Crack3
- Fluid/Blood Leak2
- Break1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Swelling/ Edema3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2023Crack; Crack
CATHETER SHOWING LOSS OF INTEGRITY (CRACK/CRACK) IN THE STRUCTURE. THE DAMAGED PART OF THE DEVICE WAS INSIDE THE PATIENT, CAUSING EDEMA AND LEAKAGE OF ADMINISTERED SOLUTIONS.
Patient problems: Swelling/ Edema
MAUDE report 16400197 ↗MalfunctionFeb 17, 2023Crack; Crack
CATHETER SHOWING LOSS OF INTEGRITY (CRACK/CRACK) IN THE STRUCTURE. THE DAMAGED PART OF THE DEVICE WAS INSIDE THE PATIENT, CAUSING EDEMA AND LEAKAGE OF ADMINISTERED SOLUTIONS.
Patient problems: Swelling/ Edema
MAUDE report 16399015 ↗MalfunctionFeb 17, 2023Leak/Splash; Leak/Splash
CATHETER WITH A HOLE IN ITS EXTENSION (DISTAL ROUTE), CAUSING MEDICATION LEAKAGE DURING INFUSION. THE DEVICE WAS NOT REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16397324 ↗MalfunctionFeb 17, 2023Crack; Crack
CATHETER SHOWING LOSS OF INTEGRITY (CRACK/CRACK) IN THE STRUCTURE. THE DAMAGED PART OF THE DEVICE WAS INSIDE THE PATIENT, CAUSING EDEMA AND LEAKAGE OF ADMINISTERED SOLUTIONS.
Patient problems: Swelling/ Edema
MAUDE report 16396718 ↗MalfunctionSep 27, 2022Fluid/Blood Leak; Fluid/Blood Leak
CATHETER SHOWING FAILURE IN THE ROUTES WHEN INFUSING MEDICATION THROUGH THE DISTAL ROUTE, IT RETURNS THROUGH THE PROXIMAL ROUTE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15495645 ↗MalfunctionSep 23, 2022Fluid/Blood Leak; Fluid/Blood Leak
AFTER INSERTION OF THE CATHETER IN THE PATIENT, IT WAS IDENTIFIED THAT WHEN ADMINISTERING MEDICATION VIA THE PROXIMAL ROUTE, IT RETURNS VIA THE DISTAL ROUTE. THE CATHETER WAS REMOVED AND TESTED BY THE CUSTOMER AND THE PROBLEM WAS CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15472646 ↗MalfunctionOct 11, 2017Break; Break
DURING PASSAGE OF THE CATHETER INTO THE RIGHT FEMORAL, THE GUIDEWIRE RUPTURED, WITH A NEED FOR A SURGICAL PROCEDURE IN THE PATIENT TO REMOVE THE PIECE OF MATERIAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6939882 ↗
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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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