Cook TPN G03319Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002033191), received between Oct 22, 2014 and Jul 10, 2020 — classified as 12 injuries.

The most frequently reported specific device problem is “Break” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2020Break; Break

  IT WAS REPORTED THAT A COOK TPN TRIPLE LUMEN TPN CATHETER SET WAS FOUND TO BE BROKEN AND LEAKING. THE DEVICE WAS PLACED IN THE JUGULARIS INTERNA RIGHT ON (B)(6) 2020 AND SECURED TO THE PATIENT USING SUTURES AND A BANDAGE. WHEN NOT IN USE, THE CATHETER WAS MAINTAINED WITH A HEPARIN LOCK. THE PATIENT WAS REPORTED TO BE BEDRIDDEN. DATE OF EVENT WAS ORIGINALLY REPORTED AS (B)(6) 2020. ADDITIONAL INFORMATION WAS RECEIVED STATING ON 03JUN2020, THE NURSE NOTICED THAT THE BED WAS WET WHERE THE THREE LUMENS OF THE CENTRAL VENOUS CATHETER WERE LOCATED. IT WAS NOTED THAT THE CATHETER HAD BEEN "PIERCED" JUST BEFORE THE CATHETER DIVIDED INTO THREE LUMENS. THE DEVICE HAD BEEN INDWELLING FOR 8 WEEKS. NO PROBLEMS WITH FLUSHING OR DRAWING FLUIDS FROM THE CATHETER HAD BEEN NOTICED. THE CATHETER WAS SUBSEQUENTLY REMOVED AND REPLACED UNDER FULL ANESTHESIA. ABOUT SIX HOURS POST-PROCEDURE, THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT DUE TO SEPSIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND SPENT TWO AND A HALF WEEKS IN THE ICU. THE PATIENT STILL HAS INPATIENT STATUS.

  Patient problems: No Code Available; Sepsis

  MAUDE report 10260325 ↗
• InjuryJul 10, 2020Break; Break

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

  Patient problems: No Code Available

  MAUDE report 10259751 ↗
• InjuryJul 10, 2020Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT A COOK TPN TRIPLE LUMEN TPN CATHETER SET WAS FOUND TO BE BROKEN AND LEAKING. THE DEVICE WAS PLACED IN THE JUGULARIS INTERNA RIGHT AND SECURED TO THE PATIENT USING SUTURES AND A BANDAGE. WHEN NOT IN USE, THE CATHETER WAS MAINTAINED WITH A HEPARIN LOCK. THE PATIENT WAS REPORTED TO BE ACTIVE. ON (B)(6) 2020, WHILE FLUSHING THE DEVICE, BLOOD WAS FOUND TO BE SLOWLY SEEPING OUT OF THE CATHETER, JUST BEFORE IT SPLITS INTO THREE LUMENS. NO OTHER PROBLEMS WERE NOTED WITH FLUSHING OR DRAWING FLUIDS. THE DEVICE HAD BEEN INDWELLING FOR 8 WEEKS. THE CATHETER WAS SUBSEQUENTLY REMOVED AND REPLACED UNDER FULL ANESTHESIA. NO COMPLICATIONS WERE NOTED DURING THE REPLACEMENT PROCEDURE. THE PATIENT NOW HAS OUTPATIENT STATUS.

  Patient problems: No Code Available

  MAUDE report 10259154 ↗
• InjuryMar 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 8408314 ↗
• InjuryMay 10, 2018Material Separation; Material Separation

  IT WAS REPORTED A TPN TRIPLE LUMEN CATHETER LCVC LINE SNAPPED AT THE PROXIMAL END INSIDE A PATIENT. THIS PATIENT HAD NOROVIRUS. AS REPORTED, THIS COULD HAVE BEEN CAUSED BY MOVEMENT. THE LINE WAS REMOVED AND REPLACED. TO DATE, ADDITIONAL PATIENT AND EVENT INFORMATION HAS NOT BEEN MADE AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 7501922 ↗
• InjuryDec 21, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE COOK TPN TRIPLE LUMEN TPN CATHETER BROKE TOO EARLY. THE CATHETER REPORTEDLY LASTED FOR APPROXIMATELY 5 WEEKS BEFORE THEY BROKE; SPECIFIC FIGURES WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN MADE AVAILABLE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN, BUT AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED IDENTIFIED A NEW PICC LINE HAD TO BE PLACED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7139053 ↗
• InjuryDec 21, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE COOK TPN TRIPLE LUMEN TPN CATHETER BROKE TOO EARLY. THE CATHETER REPORTEDLY LASTED FOR APPROXIMATELY 5 WEEKS BEFORE THEY BROKE; SPECIFIC FIGURES WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN MADE AVAILABLE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN, BUT AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED IDENTIFIED A NEW PICC LINE HAD TO BE PLACED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7138927 ↗
• InjurySep 1, 2017Material Deformation; Material Deformation

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE SMALLEST LUMEN OF THE COOK TPN TRIPLE LUMEN TPN CATHETER HAD A VISIBLY APPARENT EXTERNAL BULGE IN THE LINE. THIS WAS DISCOVERED WHILE THE OPERATOR WAS ACCESSING THE LINE OF THE COOK TPN TRIPLE LUMEN TPN CATHETER, AND FLUSHING THE LUMENS WITH A STANDARD TURBULENT FLUSH TECHNIQUE. THE SMALLEST LUMEN FELT AS IF IT HAD "GIVE" TO IT WITH EACH TURBULENT FLUSH. THE CATHETER WAS REMOVED AND REPLACED, AND THE PATIENT WAS DISCHARGED UNEVENTFULLY. THE PRODUCT IS AVAILABLE TO BE RETURNED.

  Patient problems: No Code Available

  MAUDE report 6839628 ↗
• InjuryMay 12, 2016Break; Break

  WHEN THE NURSE ATTEMPTED TO FLUSH, ONE OF THE THREE LUMENS BROKE. THE PATIENT REQUIRED A DEVICE EXCHANGE.

  Patient problems: No Code Available

  MAUDE report 5651316 ↗
• InjuryMay 10, 2016Break; Break

  WHEN THE NURSE ATTEMPTED TO FLUSH THE CATHETER, ONE OF THE THREE LUMEN PORTIONS BROKE. THE PATIENT REQUIRED A DEVICE EXCHANGE.

  Patient problems: No Code Available

  MAUDE report 5644569 ↗
• InjuryApr 13, 2016Material Separation; Material Separation

  DURING REMOVAL OF THE CATHETER, THE USER PULLED THE DISTAL PORTION OF THE THREE WAY CATHETER WHEN IT SEPARATED. AS IT WAS APPROXIMATELY 1 INCH OUT OF THE PATIENT, THE USER SIMPLY PULLED OUT THE REMAINING PORTION FROM THE BODY OF THE PATIENT. THERE WAS NO CONSEQUENCE TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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 5574644 ↗
• InjuryOct 22, 2014Material Separation

  AS PER PROBLEM STATEMENT: DEVICE WAS BEING ACCESSED WITH 10 ML SYRINGE WHEN THE END OF THE YELLOW LUMEN SNAPPED OFF CATHETER YELLOW LUMEN ARM. THE DEVICE HAD TO BE REPAIRED WHICH DELAYED PT TREATMENT AND REQUIRED OTHER CANULA TO BE PLACED INSTEAD OF TRIPLE LUMEN CATHETER DURING A TRANSPLANT. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT PROVIDED BY THE REPORTER.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 4230332 ↗