Cook G04136Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002041363), received between Jan 10, 2019 and Feb 16, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (4 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.

• MalfunctionFeb 16, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED AN (B)(6), FEMALE PATIENT REQUIRED A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET FOR CVC PLACEMENT IN THE FEMORAL VEIN. THE PATIENT HAD A CVC IN PLACE FOR SIX DAYS WHEN PERFORATION OF THE LINE WAS DISCOVERED. THE DEVICE WAS REMOVED. AFTER INSERTION OF THE SECOND LINE, PERFORATION OF THE CENTRAL LUMEN WAS ALSO NOTED. THE DEVICE WAS REMOVED AND A CHANGE OF CENTRAL ACCESS WAS COMPLETED. NO ADVERSE EFFECTS WERE REPORTED. THE FIRST DEVICE PLACED IN THIS PATIENT WAS REPORTED UNDER MEDWATCH REPORT NUMBER: 1820334-2021-01441. THIS REPORT CAPTURES THE SECOND CATHETER.

  Patient problems: Needle Stick/Puncture

  MAUDE report 13541732 ↗
• MalfunctionFeb 16, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THE MIDDLE LUMEN OF TWO CATHETERS FROM TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SETS WERE PUNCTURED AND LEAKED. THE FIRST DEVICE WAS FLUSHED WITH SALINE AND PLACED IN THE PATIENT. UPON INFUSION OF MEDICATION, LEAKAGE WAS NOTED AT THE MANIFOLD/TUBING CONNECTION OF THE CENTER LUMEN. THE DEVICE WAS REMOVED. A SECOND DEVICE WAS FLUSHED AND AGAIN A LEAK WAS NOTED IN THE SAME LOCATION, SO THE DEVICE WAS NOT PLACED IN THE PATIENT. A NEW DEVICE WAS PLACED TO COMPLETE THE PROCEDURE. IT WAS ALSO NOTED THAT THE DEVICE WAS SECURED TO THE PATIENT VIA NEEDLE AND SUTURE. NO ADVERSE EFFECTS WERE REPORTED. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MEDWATCH REPORT NUMBERS 1820334-2021-01441 AND 1820334-2021-01442. HOWEVER, UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THIS INCIDENT WAS INDEPENDENT OF THOSE PREVIOUSLY REPORTED. THUS, PROMPTING THE SUBMISSION OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541645 ↗
• MalfunctionJun 2, 2021Material Puncture/Hole; Material Puncture/Hole

  UPON FURTHER INVESTIGATION, IT WAS DETERMINED THE TWO DEVICES PREVIOUSLY INTERPRETED AS PART OF THE SAME INCIDENT OCCURRED DURING A DIFFERENT EVENT. THIS REPORT WILL NOW CAPTURE ONE USED TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET FROM LOT 9938185 IN WHICH THE MIDDLE LUMEN WAS PERFORATED. THIS EVENT OCCURRED IN THE MONTH PRIOR TO (B)(6) 2021. NO OTHER DETAILS REGARDING THIS EVENT HAVE BEEN PROVIDED. THE SECOND DEVICE PREVIOUSLY REPORTED UNDER THIS REPORT NUMBER IS BEING CAPTURED IN MEDWATCH REPORT NUMBER: 1820334-2022-00234.

  Patient problems: Insufficient Information; Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922193 ↗
• InjuryJun 2, 2021Material Puncture/Hole; Material Puncture/Hole

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

  Patient problems: Needle Stick/Puncture

  MAUDE report 11922121 ↗
• InjuryJan 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER LEAKED AT THE BLUE CONNECTION WHEN FLUSHED FOLLOWING INSERTION. THE DEVICE WAS REMOVED AND A SECOND DEVICE WAS PLACED WITH NO INCIDENT DURING THE SAME PROCEDURE. TO DATE, ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUIRED BUT NOT YET PROVIDED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 8237247 ↗