Cook TPN G02120Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002021204), received between Oct 17, 2014 and Jun 13, 2018 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2018Break

  THE COMPLAINANT REPORTED THAT THE REPAIRING CATHETER FROM THE COOK TPN SINGLE LUMEN CATHETER REPAIR SET BROKE IN THE STIFF PART AT THE INSERTION STAGE AT THE LEVEL OF THE ENTRANCE. THIS PRODUCT PROBLEM OCCURRED AFTER THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 7596468 ↗
• MalfunctionJun 13, 2018Break

  THE COMPLAINANT REPORTED THAT THE REPAIRING CATHETER FROM THE COOK TPN SINGLE LUMEN CATHETER REPAIR SET BROKE IN THE STIFF PART AT THE INSERTION STAGE AT THE LEVEL OF THE ENTRANCE. THIS PRODUCT PROBLEM OCCURRED AFTER THE PROCEDURE.

  Patient problems: No Information

  MAUDE report 7595992 ↗
• InjuryMay 7, 2018Fracture; Leak/Splash; Fracture; Leak/Splash

  IT WAS REPORTED DURING A REPAIR OF AN LT CVC LINE, A COOK TPN SINGLE LUMEN CATHETER REPAIR SET WAS FOUND TO LEAK NEAR THE HUB. A PIN PRICK HOLE WAS FOUND AFTER THE REPAIR LINE WAS GLUED IN PLACE WHEN ATTEMPTING TO FLUSH AND CHECK THE LINE. TO DATE, ADDITIONAL PATIENT AND EVENT INFORMATION HAS NOT BEEN MADE AVAILABLE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7489815 ↗
• InjurySep 26, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE PART OF THE COOK TPN SINGLE LUMEN CATHETER REPAIR SET "WHICH IS NORMALLY CONNECTED WITH THE REST OF THE INTERNAL PART, NAKED ITSELF" [SIC]. THE CUSTOMER CONFIRMED THAT, AS A DIRECT RESULT OF THE PRODUCT PROBLEM, THE OPERATOR HAD TO CHANGE OUT THE DEVICE. ADDITIONALLY, THE PEDIATRIC PATIENT EXPERIENCED BLEEDING AND ANTIBIOTHERAPY WAS NECESSITATED. THE CONDITIONS SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE NOT KNOWN. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 6895235 ↗
• InjurySep 26, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE PART OF THE COOK TPN SINGLE LUMEN CATHETER REPAIR SET "WHICH IS NORMALLY CONNECTED WITH THE REST OF THE INTERNAL PART, NAKED ITSELF" [SIC]. THE CUSTOMER CONFIRMED THAT, AS A DIRECT RESULT OF THE PRODUCT PROBLEM, THE OPERATOR HAD TO CHANGE OUT THE DEVICE. THE CONDITIONS SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE NOT KNOWN. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. THIS WAS A PEDIATRIC PATIENT.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 6895228 ↗
• MalfunctionAug 3, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A CUSTOMER CALLED AND STATED "WHEN THE FEEDING CATHETER WHICH WAS CRACKED ON THE CHILD WHO WAS WEARING IT FOR A WHILE THE GUIDE DID NOT FIT IN THE CATHETER." ADDITIONAL EVENT INFORMATION WAS REQUESTED; NO FURTHER INFORMATION WAS PROVIDED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6764397 ↗
• MalfunctionOct 17, 2014Break

  THE TPR LINES ARE BREAKING. THE REPAIR TUBE IS BREAKING--EITHER WHILE THEY'RE BEING USED TO REPAIR AN ORIGINAL LINE OR IS ALREADY BROKEN WHEN IT COMES OUT OF THE PACKAGE. ADDITIONAL INFORMATION REQUESTED ((B)(6) 2014 AND (B)(6) 2014) BUT NOT PROVIDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4269322 ↗