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Cook G08704Recalls & reported problems

Cook Incorporated · Multi-Sideport Catheter Infusion Set Dual Check Valve · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002087040), received between Nov 7, 2018 and Feb 25, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak1
  • Fracture1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 25, 2019Fracture; Fracture

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8366086 ↗
  • MalfunctionNov 7, 2018Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED, A MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET WAS UTILIZED FOR TREATMENT OF PHLEBOTHROMBOSIS (BLOOD CLOT NOT ASSOCIATED WITH INFLAMMATION). A THROMBOLYSIS PROCEDURE WHEREBY UROKINASE AND HEPARIN WERE BEING INFUSED THROUGH THE SIDEPORT'S TO DISSOLVE THE CLOT WAS UNDERWAY WHEN A LEAK WAS NOTED COMING FROM THE CONNECTION OF THE Y VALVE. A POWER INJECTOR WAS NOT IN USE. NO RESISTANCE WAS ENCOUNTERED UPON INSERTION OR REMOVAL OF THIS DEVICE. THE PHYSICIAN REPLACED THE COMPLAINT DEVICE WITH A SECOND MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET FROM THE SAME LOT AND THIS DEVICE LEAKED AS WELL. THE PROCEDURE WAS ABLE TO BE COMPLETED USING ANOTHER MANUFACTURER'S DEVICE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ACCORDING TO THE COMPLAINANT, ONLY ONE MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET WILL BE RETURNED TO AID THE MANUFACTURER'S INVESTIGATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8047531 ↗

Other Catheter, continuous flush devices

All Catheter, continuous flush devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.