Cook Spectrum G23763Recalls & reported problems
Cook Incorporated · Spectrum, Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter · Class 2
All models of Cook Spectrum (67)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002237636), received between Jul 11, 2018 and Dec 27, 2018 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 16, 2026.
Most reported problems
Device problems
- Contamination /Decontamination Problem2
- Device Contamination with Chemical or Other Material1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient2
- No Code Available1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8199263 ↗MalfunctionDec 27, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8199017 ↗MalfunctionDec 20, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Patient Involvement
MAUDE report 8187355 ↗InjuryJul 11, 2018Fracture; Fracture
IT WAS REPORTED A 9FR SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER ( CVC) WAS USED FOR A CENTRAL LINE INSERTION ON AN UNKNOWN DATE. ON THE (B)(6) 2018 AT 9 WHEN THE CAP WAS REPLACED IT APPEARED FINE AND AT 0430 ON (B)(6) 2018 IT WAS NOTICED THE BLUE LUMEN WAS LEAKING FROM THE HUB. THERE WAS A CRACKED HUB NOTED WHERE THE LINE EXTENSION MEETS. THE CVC LINE WAS REMOVED AND A NEW CVC LINE WAS PLACED. IT WAS FURTHER STATED THERE IS "THE POSSIBILITY THAT INDIVIDUALS ARE SCREWING THE END CAPS ON TOO TIGHT". NO OTHER PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Code Available
MAUDE report 7680496 ↗
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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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