Cook TPN G08074Recalls & reported problems
Cook Incorporated · Cook TPN, Double Lumen Catheter Set With 13Fr Peel-Away, Introducer Set · Class 2 · Implant
All models of Cook TPN (17)
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 00827002080744), received between Aug 3, 2017 and Aug 3, 2017 — 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
- Detachment Of Device Component1
- Kinked1
- Split1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2017Break; Detachment Of Device Component; Kinked; Split
THE INFORMATION RECEIVED INDICATED THAT THE TIP OF THE DILATOR WAS DAMAGED DURING AN INSERTION ATTEMPT. THE REPORTER INDICATED THAT DUE TO THE EXTREME OBESITY OF PATIENT OR CURVATURE OF VEIN AND OBSTACLE OF CLAVICLE, THE APPROPRIATE TWISTING MOTION WAS USED, AT THIS POINT THE INTRODUCER KINKED AND THE TIP OF THE DILATOR WAS DAMAGED. EVALUATION OF THE RETURNED DEVICE INDICATED THE DILATOR HAD BEEN SPLIT BEGINNING AT THE TIP AND EXTENDING 3MM PROXIMALLY. THE DEVICE HAD BEEN SPLIT SO THAT ALMOST HALF THE TIP HAD DETACHED AT AN ANGLE, THE SECOND DILATOR HAD A 1MM SPLIT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED WITH THE USE OF A NEW SET. ACCORDING TO THE INITIAL REPORTER THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Information
MAUDE report 6764243 ↗
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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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