Cook G02854Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002028548), received between Nov 26, 2019 and Apr 17, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (5 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN INSERTING A WIRE GUIDE THROUGH THE NEEDLE OF A SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY DURING AN ARTERIAL LINE PLACEMENT PROCEDURE. THE USER WAS TESTING THE DEVICE BEDSIDE BEFORE STARTING THE PROCEDURE WHEN THE RESISTANCE WAS NOTED. THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9971619 ↗
• MalfunctionApr 15, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN INSERTING A WIRE GUIDE THROUGH THE NEEDLE OF A SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY DURING AN ARTERIAL LINE PLACEMENT PROCEDURE. THE USER WAS TESTING THE DEVICE BEDSIDE BEFORE STARTING THE PROCEDURE WHEN THE RESISTANCE WAS NOTED. THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9962800 ↗
• MalfunctionApr 14, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE NEEDLE OF A SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY DID NOT GIVE BLOOD RETURN DURING AN ARTERIAL PRESSURE MONITORING PROCEDURE. AFTER INSERTION, SALINE WAS FLUSHED THROUGH THE NEEDLE AND THE WIRE GUIDE WAS ATTEMPTED TO BE ADVANCED THROUGH THE NEEDLE. WHEN THE USER INSERTED THE NEEDLE, THEY DID NOT GET "FLASHBACK" AND EXPERIENCED DIFFICULTY INSERTING THE WIRE GUIDE THROUGH THE NEEDLE. IT WAS STATED THAT "IT IS SUSPECTED THAT THE VESSEL HAD NOT BEEN ACCESSED". THE PATIENT WAS ALREADY IN THE ICU AT THE TIME OF THE EVENT AND WAS RECEIVING THE DEVICE FOR ARTERIAL PRESSURE MONITORING. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9959067 ↗
• MalfunctionMar 13, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE WIRE GUIDE WOULD NOT PASS THROUGH THE NEEDLE INCLUDED IN A SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY. WHILE PLACING A PERIPHERAL ARTERIAL LINE, THE PHYSICIAN WAS UNABLE TO GET BLOOD RETURN DESPITE USING AN ULTRASOUND FOR VISUAL AID. AT THIS POINT, THE PHYSICIAN COULD NOT ADVANCE THE WIRE GUIDE THROUGH THE NEEDLE TO COMPLETE THE PROCEDURE. AFTER "A COUPLE OF ATTEMPTS", THE PHYSICIAN OBTAINED A SECOND KIT. UNFORTUNATELY, THE PHYSICIAN RAN INTO THE SAME ISSUE. EVENTUALLY, THE PHYSICIAN WAS ABLE TO GET THE WIRE THROUGH THE NEEDLE "WITH SOME DIFFICULTY" BUT "FELT A POP" RIGHT BEFORE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9830940 ↗
• MalfunctionNov 26, 2019Complete Blockage; Delivered as Unsterile Product; Complete Blockage; Delivered as Unsterile Product

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9377446 ↗