Cook G02937Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002029378), received between Jun 25, 2018 and Feb 3, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HUB OF A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER CAME LOOSE DURING MANIPULATION. THE DEVICE WAS PLACED ON (B)(6) 2021 IN THE RIGHT SUBCLAVIAN VEIN FOR DEEP VENOUS ACCESS. ON (B)(6) 2021, IT WAS NOTED TO HAVE A "RED PATHWAY DEFECT." WHEN MANIPULATING THE CATHETER, THE HUB OF ONE OF THE LUMENS CAME LOOSE. AN ADDITIONAL PROCEDURE WAS NEEDED TO REMOVE AND REPLACE THE DEVICE. THE VENOUS ACCESS WAS CHANGED DUE TO THE PATIENT'S CLINICAL CONDITIONS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13444892 ↗
• MalfunctionDec 2, 2019Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Patient Involvement

  MAUDE report 9397029 ↗
• MalfunctionJul 16, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING THE DISTRIBUTOR'S PACKAGING INSPECTION OF A COOK TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET, A SMALL HOLE WAS DETECTED IN THE BACK OF THE PACKAGE. IT WAS ALSO NOTED THAT THE PRIMARY PACKAGE WAS DAMAGED.

  Patient problems: No Patient Involvement

  MAUDE report 8794204 ↗
• MalfunctionJul 3, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET WAS USED DURING A RESEARCH STUDY TO RETRIEVE CEREBRAL VENOUS BLOOD SAMPLES. THE LINE WAS IN PLACE FOR APPROXIMATELY 5 HOURS AND SAMPLES WERE TAKEN EVERY 5-10 MINUTES. THE LINE WAS FLUSHED FREQUENTLY WITH SALINE AFTER SAMPLES WERE TAKEN. SIGNIFICANT CLOTS WITHIN THE INTERNAL JUGULAR VEIN WERE OBSERVED AND MEASURED VIA DUPLEX ULTRASOUND. THE PROGRESSION OF THESE CLOTS WERE TRACKED AND SAID TO DISSIPATE. AS REPORTED, THE ISSUE OF CLOTTING WAS NOT NOTED WHEN DIFFERENT CATHETERS WERE USED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7660214 ↗
• MalfunctionJul 3, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET WAS USED DURING A RESEARCH STUDY TO RETRIEVE CEREBRAL VENOUS BLOOD SAMPLES. THE LINE WAS IN PLACE FOR APPROXIMATELY 5 HOURS AND SAMPLES WERE TAKEN EVERY 5-10 MINUTES. THE LINE WAS FLUSHED FREQUENTLY WITH SALINE AFTER SAMPLES WERE TAKEN. SIGNIFICANT CLOTS WITHIN THE INTERNAL JUGULAR VEIN WERE OBSERVED AND MEASURED VIA DUPLEX ULTRASOUND. THE PROGRESSION OF THESE CLOTS WERE TRACKED AND SAID TO DISSIPATE. AS REPORTED, THE ISSUE OF CLOTTING WAS NOT NOTED WHEN DIFFERENT CATHETERS WERE USED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7660213 ↗
• MalfunctionJun 25, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET WAS USED DURING A RESEARCH STUDY TO RETRIEVE CEREBRAL VENOUS BLOOD SAMPLES. THE LINE WAS IN PLACE FOR APPROXIMATELY 5 HOURS AND SAMPLES WERE TAKEN EVERY 5-10 MINUTES. THE LINE WAS FLUSHED FREQUENTLY WITH SALINE AFTER SAMPLES WERE TAKEN. SIGNIFICANT CLOTS WITHIN THE INTERNAL JUGULAR VEIN WERE OBSERVED AND MEASURED VIA DUPLEX ULTRASOUND. THE PROGRESSION OF THESE CLOTS WERE TRACKED AND SAID TO DISSIPATE. AS REPORTED, THE ISSUE OF CLOTTING WAS NOT NOTED WHEN DIFFERENT CATHETERS WERE USED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7635640 ↗