Cook TPN G01873Recalls & reported problems
Cook Incorporated · Cook TPN, Single Lumen Catheter · Class 2 · Implant
All models of Cook TPN (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002018730), received between Sep 12, 2017 and Sep 25, 2017 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Material Protrusion/Extrusion2
- Material Separation2
Patient problems
- No Known Impact Or Consequence To Patient5
- No Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2017Fluid/Blood Leak
THE COMPLAINANT REPORTED THAT THE LINE WAS LEAKING 2 INCHES FROM "WHERE THICK MEETS THIN." THERE WERE NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6891740 ↗MalfunctionSep 25, 2017Fluid/Blood Leak
THE COMPLAINANT REPORTED THAT THE LINE WAS LEAKING AND IT WAS REPAIRED WITH A REPAIR KIT. NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6891629 ↗MalfunctionSep 22, 2017Material Separation
IT WAS REPORTED THE OUTER LUMEN OF THE PICC LINE WAS SEPARATING FROM INNER LUMEN WHERE THICK MEETS THIN. THERE WERE NO ISSUES THE WITH REPAIR OF THE LINE. THERE WERE NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6888005 ↗MalfunctionSep 15, 2017Material Separation
THE COMPLAINANT REPORTED THAT THE OUTER LUMEN OF THE SINGLE LUMEN TPN CATHETER SEPARATED AND THE INNER LUMEN REMAINED INTACT. IT WAS ALSO REPORTED THAT THE REPAIR WAS DIFFICULT AND 2 KITS WERE REQUIRED TO DO THE REPAIR SINCE THE GUIDE WIRE WOULD NOT PASS. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6869818 ↗MalfunctionSep 13, 2017Material Protrusion/Extrusion
IT WAS REPORTED THERE WAS BULGING AT THE CLAMP SITE OF THE CATHETER LINE. THE LINE WAS REPAIRED WITHOUT ISSUE.
Patient problems: No Information
MAUDE report 6860961 ↗MalfunctionSep 12, 2017Material Protrusion/Extrusion
IT WAS REPORTED THERE WAS BULGING AT THE CLAMP SITE OF THE CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6858950 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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