Cook G02244Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002022447), received between Dec 12, 2019 and Nov 8, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2023Break; Crack; Leak/Splash; Break; Crack; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093290 ↗
• MalfunctionJan 2, 2020Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE CATHETER OF A SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY APPEARS TO BE BROKEN AT THE "CONNECTOR CONNECTION" AND LEAKS. THE COMPLAINT CATHETER WAS PLACED "BY THE RIGHT SUBCLAVIAN" AND WAS BEING USED FOR TREATMENT WITH TOTAL PARENTERAL NUTRITION. PREVIOUSLY, A CATHETER WAS CHANGED THE FIRST TIME "OVER THE WIRE" DUE TO LEAKING AND CHANGED AGAIN "OVER THE WIRE" DUE TO BREAKING AND LEAKING. THE PATIENT WAS REPORTED TO NOT HAVE RECEIVED ORDERED TREATMENT AND CONSEQUENTLY PRESENTED WITH A LOW BLOOD GLUCOSE LEVEL. ADDITIONAL INFORMATION REGARDING PATIENT, EVENT, AND DEVICE DETAILS HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hypoglycemia

  MAUDE report 9537728 ↗
• InjuryDec 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER USED TO ADMINISTER MEDICATION AND TPN IN AN INFANT WAS FOUND LEAKING. THE LINE WAS IMPLANTED IN THE RIGHT SUBCLAVIAN VEIN ON (B)(6) 2019 AND EXPLANTED ON (B)(6) 2019, AND FAILED DURING TREATMENT. MEDICATIONS INCLUDING RANITIDINE, AMINO ACIDS, AND FAT EMULSION BETWEEN OTHERS WERE USED WITH THIS CATHETER. THE DEVICE WAS SECURED TO THE PATIENT WITH SUTURES AND AN ADDITIONAL BANDAGE FOR CENTRAL CATHETERS. THE CATHETER WAS NOT PROCESSED IN ANY FORM BEFORE THE PLACEMENT DATE AND NO ANCILLARY DEVICES WERE USED AT THE TIME OF FAILURE. THE PATIENT WAS A (B)(6) MONTH OLD FEMALE WEIGHING (B)(6) KILOGRAMS. THE ACTIVITY LEVEL OF THE PATIENT WAS NORMAL FOR A CHILD OF 3 MONTHS AT ROOM AIR IN THE NEONATAL INTENSIVE CARE UNIT. THE PATIENT HAS NO KNOWN ALLERGIES. X-RAY IMAGING WAS PERFORMED TO CONFIRM THE CATHETER WAS STILL IN POSITION. AN ADDITIONAL PROCEDURE WAS REQUIRED IN ORDER TO PLACE ANOTHER CATHETER.

  Patient problems: No Code Available

  MAUDE report 9461252 ↗
• InjuryDec 12, 2019Material Separation; Material Separation

  THE CORRESPONDING MEDWATCH REPORT (MW5091355) WAS RECEIVED ON 16DEC2019. IT WAS REPORTED THAT THE PATIENT HAD CENTRAL ACCESS IN THE INTERNAL JUGULAR VEIN. THE DEVICE WAS FOUND DETACHED AT "THE FIXATIVE OF HE VENOUS CATHETER". A CHEST PLATE WAS MADE AND THE CATHETER REMAINED INSIDE THE PATIENT. THE PATIENT WAS SENT TO THE OPERATING ROOM TO REMOVE THE PORTION OF THE CATHETER FROM THEIR VEIN.

  Patient problems: No Code Available

  MAUDE report 9461062 ↗