Cook TPN G07935Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002079359), received between Oct 25, 2016 and Aug 6, 2021 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 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.

• InjuryAug 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12286877 ↗
• InjuryJul 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12143352 ↗
• InjuryJun 11, 2021Crack; Crack

  IT WAS REPORTED A MALE PATIENT REQUIRED A REDO DOUBLE LUMEN TPN CATHETER SET FOR AN UNKNOWN PROCEDURE. SOME TIME AFTER THE PROCEDURE, THE DEVICE WAS NOTED TO HAVE CRACKED. AN ADDITIONAL SURGERY WAS REQUIRED FOR THE "CONSTRUCTION" OF A NEW DEVICE ON THE LEFT SIDE OF THE PATIENT. THE PATIENT REPORTEDLY "SUFFERED FROM REQUIRED INPATIENT CARE AND PSYCHOSOCIAL STRESS". ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Distress; Scar Tissue

  MAUDE report 11983790 ↗
• InjuryFeb 9, 2021Fluid/Blood Leak

  IN ADDITIONAL INFORMATION RECEIVED ON 19FEB2021, IT WAS REPORTED THAT THE CATHETER WAS PLACED IN THE RIGHT JUGULAR VEIN FOR PARENTERAL NUTRITION IN WHICH INFUSIONS OF TRAVASOL AND LIPIDS WERE BEING ADMINISTERED. THE DEVICE WAS SECURED TO THE PATIENT WITH THE SPECIALIZED DRESSING TEGADERM ADVANCE. THERE WAS NO DIFFICULTY ATTACHING OR DISCONNECTING ANCILLARY DEVICES SUCH AS EXTENSION WITH NEEDLELESS CONNECTORS AND DELIVERY TUBING TO THE CATHETER. PATIENT ACTIVITY LEVEL WAS DESCRIBED AS "QUITE RESTLESS." THE DEVICE FAILED DURING HYPERALIMENTATION TREATMENT. THE FIRST BREAK OCCURRED AT HOME WHERE THE CATHETER WAS HELD IN PLACE WITH KITE LOCK. THE SECOND BREAK HAD A CONTINUOUS INFUSION OF SOLUTE. THERE WAS A NEED FOR RELOCATION OF ANOTHER CENTRAL LINE. THE PATIENT WAS HOSPITALIZED OR REQUIRED PROLONGED HOSPITALIZATION. THE DEVICE IS NOT AVAILABLE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11301124 ↗
• InjuryFeb 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IN ADDITIONAL INFORMATION RECEIVED ON 19FEB2021, IT WAS REPORTED THAT THE CATHETER WAS PLACED IN THE RIGHT JUGULAR VEIN FOR PARENTERAL NUTRITION IN WHICH INFUSIONS OF TRAVASOL AND LIPIDS WERE BEING ADMINISTERED. THE DEVICE WAS SECURED TO THE PATIENT WITH THE SPECIALIZED DRESSING TEGADERM ADVANCE. THERE WAS NO DIFFICULTY ATTACHING OR DISCONNECTING ANCILLARY DEVICES SUCH AS EXTENSION WITH NEEDLELESS CONNECTORS AND DELIVERY TUBING TO THE CATHETER. PATIENT ACTIVITY LEVEL WAS DESCRIBED AS "QUITE RESTLESS." THE DEVICE FAILED DURING HYPERALIMENTATION TREATMENT. THE FIRST BREAK OCCURRED AT HOME WHERE THE CATHETER WAS HELD IN PLACE WITH KITE LOCK. THE SECOND BREAK HAD A CONTINUOUS INFUSION OF SOLUTE. THERE WAS A NEED FOR RELOCATION OF ANOTHER CENTRAL LINE. THE PATIENT WAS HOSPITALIZED OR REQUIRED PROLONGED HOSPITALIZATION. THE DEVICE IS NOT AVAILABLE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 11300867 ↗
• InjuryDec 3, 2020Material Separation; Material Separation

  IN THE DEVICE FAILURE ANALYSIS SIGNED ON (B)(6) 2021, IT WAS FOUND THAT THE RED HUB PLUNGER WOULD NOT RELEASE FLUID. ENCRUSTATION WAS NOTED ON THE DEVICE. WHILE FLUID WAS ABLE TO EXIT THE DISTAL TIP OF THE BLUE HUB, A LOT OF RESISTANCE WAS NOTED IN DOING SO.

  Patient problems: No Code Available

  MAUDE report 10941399 ↗
• InjuryJan 13, 2020Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE, A REDO DOUBLE LUMEN TPN CATHETER WAS BENT AND STARTED LEAKING. THE CATHETER WAS REMOVED ON THE SAME DAY AS THE INCIDENT OCCURRED AND A NEW CATHETER WAS PLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING PATIENT AND EVENT DETAILS BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9580714 ↗
• InjuryJan 30, 2019Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 8290090 ↗
• InjuryJun 23, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT A PEDIATRIC PATIENT HAD A REDO DOUBLE LUMEN TPN CATHETER IMPLANTED ON AN UNSPECIFIED DATE. THE CUSTOMER REPORTS THAT THE DEVICE LEAKED BLOOD AND MEDICATION AT THE LEVEL OF THE HUB. THE CUSTOMER REMOVED THE DEVICE DRESSING AND EXAMINED THE DEVICE. CUSTOMER FOUND A FISSURE/CRACK ABOVE THE SLEEVE OF A PREVIOUS REPAIR. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

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

  MAUDE report 6662622 ↗
• MalfunctionJun 16, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT RECEIVED A REDO DOUBLE LUMEN TOTAL PARENTERAL NUTRITION (TPN) CATHETER ON (B)(6) 2017 FOR AN UNSPECIFIED INDICATION. THE CUSTOMER REPORTS THAT THE DEVICE BROKE ON (B)(6) 2017. THE CIRCUMSTANCES AND HANDLING CONDITIONS SURROUNDING THE EVENT ARE NOT KNOWN. THE DETAILS OF THE BREAK WERE NOT PROVIDED. THE DEVICE WAS EXPLANTED; IT IS NOT KNOWN WHAT OTHER ACTIONS WERE UNDERTAKEN BY THE CLINICAL STAFF TO ADDRESS THIS EVENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT. ADDITIONAL PATIENT AND EVENT INFORMATION WAS REQUESTED; NO FURTHER INFORMATION WAS RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6646114 ↗
• InjuryDec 9, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TOTAL PARENTERAL NUTRITION(TPN) CATHETER WAS NOTED TO BE LEAKING APPROXIMATELY TWO MONTHS AFTER IMPLANT. THE DEVICE WAS REPLACED WITH ANOTHER ONE. 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 Code Available

  MAUDE report 6158336 ↗
• InjuryOct 25, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED A CATHETER PLACED ON (B)(6) 2016 IN A (B)(6) FEMALE PATIENT HAD A HOLE AT THE CONNECTION OF THE CATHETER HUB RESULTING IN LEAKAGE. THE CATHETER WAS REMOVED AND A REPLACEMENT TOTAL PARENTERAL NUTRITION CATHETER WAS PLACED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Code Available

  MAUDE report 6053445 ↗