Cook TPN G01880Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002018808), received between Jul 27, 2016 and Jul 13, 2018 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2018Break; Break

  IT WAS REPORTED A COOK TPN DOUBLE LUMEN TPN CATHETER SET BROKE WHERE THE HUB AND SILICONE CATHETER CONNECT. TO DATE, ADDITIONAL INFORMATION HAS BEEN REQUESTED THREE TIMES, BUT NO ADDITIONAL INFORMATION IS AVAILABLE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7686216 ↗
• MalfunctionSep 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE CLAMP ON THE COOK TPN DOUBLE LUMEN TPN CATHETER WAS OPEN, AND WHEN THE OPERATOR ATTEMPTED TO CLOSE THE CLAMP, IT WOULD SPONTANEOUSLY REOPEN AND NOT STAY CLOSED. THE CLAMP HAD TO BE "OVER-FLEXED" IN ORDER TO KEEP IT CLOSED. THE PATIENT WAS REPORTEDLY UNAFFECTED, AND THE PRODUCT IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6893684 ↗
• MalfunctionAug 7, 2017Material Frayed

  UPON OPENING THE PACKAGE OF THE DEVICE PRIOR TO DEVICE MANIPULATION, THE PHYSICIAN NOTICED THAT THE WIRE GUIDE TIP WAS FRAYED. ANOTHER DEVICE WAS USED INSTEAD. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND THERE WERE NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6770278 ↗
• InjuryApr 13, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A COOK TOTAL PARENTERAL NUTRITION (TPN) DOUBLE LUMEN CATHETER WAS IMPLANTED INTO A PATIENT ON (B)(6) 2016. THE EXTENSION TUBING OF THE CATHETER REPORTEDLY FRACTURED ON (B)(6) 2017. (1820334-2017-00680) THE CONDITIONS AND CIRCUMSTANCES SURROUNDING THE EVENT ARE NOT KNOWN. A KIT WAS OBTAINED TO REPAIR THE DEVICE; THE REPAIR KIT DID NOT APPEAR TO BE THE PROPER SIZE FOR THE NEEDED REPAIR. (1820334-2017-00772) A SECOND REPAIR KIT WAS OBTAINED AND THE CATHETER SUCCESSFULLY REPAIRED. THE REPAIRED CATHETER THEN FRACTURED SEVERAL HOURS LATER AND WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A NEW TPN CATHETER (1820334-2017-00772) ON (B)(6) 2017. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. THE DEVICE THAT IS THE SUBJECT OF THIS REPORT IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT. THIS IS ONE OF THREE SEPARATE REPORTS BEING SUBMITTED AS THREE EVENTS WERE REPORTED. SEE MDR NUMBERS 1820334-2017-00680, 1820334-2017-00771 AND 1820334-2017-00772 FOR ALL ASSOCIATED EVENTS. THE SAME PATIENT IS INVOLVED IN ALL EVENTS.

  Patient problems: No Code Available

  MAUDE report 6490336 ↗
• MalfunctionApr 13, 2017Fitting Problem; Fitting Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A COOK TOTAL PARENTERAL NUTRITION (TPN) DOUBLE LUMEN CATHETER WAS IMPLANTED INTO A PATIENT ON (B)(6) 2016. THE EXTENSION TUBING OF THE CATHETER REPORTEDLY FRACTURED ON (B)(6) 2017. THE CONDITIONS AND CIRCUMSTANCES SURROUNDING THE EVENT ARE NOT KNOWN. (1820334-2017-00680) A KIT WAS OBTAINED TO REPAIR THE DEVICE; THE REPAIR KIT DID NOT APPEAR TO BE THE PROPER SIZE FOR THE NEEDED REPAIR (1820334-2017-00771). A SECOND REPAIR KIT WAS OBTAINED AND THE CATHETER SUCCESSFULLY REPAIRED. THE REPAIRED CATHETER THEN FRACTURED SEVERAL HOURS LATER (1820334-2017-00772) AND WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A NEW TPN CATHETER ON (B)(6) 2017. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF THREE SEPARATE REPORTS BEING SUBMITTED AS THREE EVENTS WERE REPORTED. SEE MDR NUMBERS 1820334-2017-00680, 1820334-2017-00771 AND 1820334-2017-00772 FOR ALL ASSOCIATED EVENTS. THE SAME PATIENT IS INVOLVED IN ALL EVENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6490315 ↗
• MalfunctionApr 13, 2017Fracture; Fracture

  INTERNATIONAL CUSTOMER REPORTED THAT A COOK TOTAL PARENTERAL NUTRITION (TPN) DOUBLE LUMEN CATHETER WAS IMPLANTED INTO A PATIENT ON (B)(6) 2016. THE EXTENSION TUBING OF THE CATHETER REPORTEDLY FRACTURED ON (B)(6) 2017 (1820334-2017-00680). THE CONDITIONS AND CIRCUMSTANCES SURROUNDING THE EVENT ARE NOT KNOWN. A KIT WAS OBTAINED TO REPAIR THE DEVICE; THE REPAIR KIT DID NOT APPEAR TO BE THE PROPER SIZE FOR THE NEEDED REPAIR.( 1820334-2017-00771). A SECOND REPAIR KIT WAS OBTAINED AND THE CATHETER SUCCESSFULLY REPAIRED. THE REPAIRED CATHETER THEN FRACTURED SEVERAL HOURS LATER (1820334-2017-00772), AND WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A NEW TPN CATHETER ON (B)(6) 2017. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. THE DEVICE WAS RECEIVED FOR EVALUATION. THIS IS ONE OF THREE SEPARATE REPORTS BEING SUBMITTED AS THREE EVENTS WERE REPORTED. SEE MDR NUMBERS , 1820334-2017-00680, 1820334-2017-00771 AND 1820334-2017-00772 FOR ALL ASSOCIATED EVENTS. THE SAME PATIENT IS INVOLVED IN ALL EVENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6489970 ↗
• MalfunctionJul 27, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A CATHETER, PLACED IN THE EXTERNAL JUGULAR VEIN OF THE (B)(6) OLD FEMALE PATIENT ON (B)(6) 2016, WAS LEAKING FLUID FROM THE AREA NEAR THE BASE OF THE MANIFOLD. THE LEAK WAS TEMPORARILY COVERED WITH REINFORCING TAPE ON (B)(6) 2016. ON (B)(6) 2016 THE DEVICE WAS RETRIEVED OUT OF THE PATIENT, SINCE THERAPY WAS COMPLETED AT THE SAME TIME NO ADDITIONAL DEVICE WAS PLACED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5826130 ↗