Cook TPN G01869Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002018693), received between Apr 16, 2015 and Aug 23, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 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.

• InjuryAug 23, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT HAD A TRANSLUMBAR TUNNELED CENTRAL VENOUS CATHETER (CVC) THAT REQUIRED REPAIR ON (B)(6) 2020. A REPAIR WAS COMPLETED WITH A COOK TPN SINGLE LUMEN CATHETER REPAIR SET (RPN: C-RHCS-6.5, LOT NUMBER 9836148). TWO YEARS LATER, THE SAME CVC REQUIRED ANOTHER REPAIR AT THE SAME LOCATION. DURING THE REPAIR, IT WAS NOTED THAT THE METAL ROD OF THE PREVIOUS REPAIR KIT HAD MIGRATED TOWARDS THE INSERTION POINT OF THE CATHETER AND WAS LOCATED AT THE AREA WHERE THE CVC SECUREMENT DEVICE HAD BEEN PLACED. THE METAL ROD WAS THEN PUSHED BACK TOWARDS THE CATHETER HUB BEFORE THE LUMEN WAS CUT FOR REPAIR. THE LUMEN WAS REPAIRED WITH ANOTHER COOK TPN SINGLE LUMEN CATHETER REPAIR SET, (RPN: C-RHCS-6.5, LOT NUMBER 9836148). THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15276329 ↗
• MalfunctionJul 10, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED ON 17JUL2020. IT WAS REPORTED THE CATHETER WAS FIRST PLACED ON "30DEC2020" IN THE PATIENT'S THORAX. IT IS LIKELY THE CATHETER WAS ACTUALLY PLACED ON 30DEC2019. IT WAS REPAIRED ONCE ON (B)(6) 2020 AND AGAIN ON (B)(6) 2020. AFTER EACH REPAIR THE PATIENT WAS HOSPITALIZED AS NECESSARY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10259967 ↗
• MalfunctionFeb 27, 2019Material Separation; Material Separation

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8373717 ↗
• MalfunctionApr 16, 2015Occlusion Within Device

  A DEVICE WAS PLACED IN A (B)(6) YEAR OLD MALE PATIENT. THE CATHETER BECAME CLOGGED THREE WEEKS LATER. ON (B)(6) 2015, THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER CATHETER. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 4707904 ↗