Cook G03433Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002034334), received between Dec 12, 2019 and Dec 12, 2019 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER USED FOR TPN TREATMENT IN AN INFANT PATIENT WAS FOUND TO BE LEAKING. THE DEVICE WAS USED IN THE LEFT SUBCLAVIAN VEIN ARTERY FOR THE ADMINISTRATION OF TREATMENT AND MEDICATION. TPN, INTRA LIPIDS, AND MEDICATIONS WERE THE TREATMENTS BEING PERFORMED, AND AMINO ACIDS, DEXTROSE, AND FAT EMULSION WERE BEING INFUSED. THE PATIENT WAS A (B)(6) MONTH OLD MALE WEIGHTING (B)(6) GRAMS. THE PATIENT DOES NOT HAVE ANY KNOWN ALLERGIES. THE ACTIVITY LEVEL OF THE PATIENT WAS NORMAL FOR A CHILD OF 3 MONTHS. THE DEVICE WAS SECURED TO THE PATIENT BY SUTURES AND A BANDAGE. ANCILLARY DEVICES WERE NOT USED AT THE TIME OF THE FAILURE. IT WAS REPORTED THAT THE CATHETER DID NOT SEPARATE. NO INSTRUMENTS WERE USED TO TIGHTEN OR RELEASE THE HUB. THE DEVICE FAILED DURING TREATMENT AND THE LINE WAS CHANGED OVER THE WIRE AND REPLACED WITHOUT COMPLICATIONS.

  Patient problems: No Code Available

  MAUDE report 9461303 ↗