Cook TPN G07960Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002079601), received between Apr 17, 2015 and May 12, 2020 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2020Break; Fitting Problem; Break; Fitting Problem

  A DEVICE FAILURE ANALYSIS WAS CONDUCTED ON 01JUN2020 FOR THE RETURNED DEVICE AND FOUND THAT IN ADDITION TO THE BREAK IN THE LINE, THE SILICONE SLEEVE HAS COME LOOSE FROM THE WINGED HUB, WHICH WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10048335 ↗
• MalfunctionMay 4, 2020Fitting Problem; Material Split, Cut or Torn; Fitting Problem; Material Split, Cut or Torn

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020769 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PROCEDURE PERFORMED WAS A LONG TERM CVC PLACEMENT IN THE SUBCLAVIAN VEIN. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 8911930 ↗
• InjuryDec 21, 2018Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED A REDO SINGLE LUMEN TPN CATHETER SET WAS USED TO REPAIR A COOK CATHETER DELIVERING TPN AND IRON INFUSIONS. THE COOK CATHETER WAS SAID TO HAVE "POPPED" ON (B)(6) 2018 DURING A SALINE FLUSH, WHICH CAUSED A HOLE. THE LINE WAS LOCKED WITH HEPARIN AND A CULTURE WAS TAKEN. THE CULTURE TESTED POSITIVE FOR INFECTION AND ANTIBIOTIC TREATMENT WAS GIVEN. AS REPORTED, THE PATIENT DID NOT REQUIRE AN ADDITIONAL PROCEDURE TO REPLACE THE LINE AS THE LINE WAS REPAIRED WITH THE REPAIR KIT.

  Patient problems: Unspecified Infection

  MAUDE report 8192167 ↗
• InjuryJul 19, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PEDIATRIC PATIENT RECEIVED A REDO SINGLE LUMEN TPN CATHETER ON AN UNSPECIFIED DATE FOR PARENTERAL NUTRITION. THE NURSING STAFF EARLIER CHECKED THE CATHETER AND THERE WAS NO ABNORMALITIES. THE FATHER FELT RESISTANCE AND HEARD A "CLAC" WHILE HOLDING THE CHILD. THE NURSING STAFF WAS ADVISED OF THIS BY THE FATHER AND CLAMPED THE CATHETER WITH A NON-STERILE CLAMP AND USED COMPRESSES WITH CHLORHEXIDINE. THE ACTIONS TAKEN BY THE CLINICAL STAFF FOLLOWING THIS EVENT ARE NOT KNOWN. ADDITIONAL INFORMATION WAS REQUESTED; NO FURTHER INFORMATION HAS BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 6725744 ↗
• MalfunctionJul 19, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT RECEIVED A REDO SINGLE LUMEN TPN CATHETER IMPLANTED ON (B)(6) 2017 FOR AN UNSPECIFIED INDICATION. THE PATIENT UNDERWENT INFUSION OF CONTRAST MEDIA DURING A THERAPY PROCEDURE ON (B)(6) /2017. LEAKAGE OF CONTRAST FLUID FROM THE CENTRAL VENOUS CATHETER WAS OBSERVED UNDER X-RAY VIEWING DURING THE PROCEDURE. THE LEAK WAS OBSERVED AROUND THE DEVICE HUB AND RIGHT JUGULAR VEIN. THE CUSTOMER REPORTS THAT "NO TRACTION OR OTHER TRAUMATIC ACTION WERE DONE." THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL PROCEDURES OR OTHER INTERVENTION WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT. THE MINISTRY OF HEALTH FORM WAS RECEIVED FROM THE NATIONAL COMPETENT AUTHORITY (ITALY) AND CONTAINED THE FOLLOWING INFORMATION: "CVC POSITIONED ON THE (B)(6) 2017. ON THE (B)(6) 2017 AN X-RAY TO THE THORAX WAS PERFORMED. AT RADIOSCOPIC EXAMINATION DURING THE ADMINISTRATION OF AROUND 1.5ML OF MDC THROUGH A CVC WE OBSERVED A SPILLAGE OF MDC AROUND THE CATHETER BOTH BY THE INSERTION AT THE RIGHT JUGULAR VEIN LEVEL AN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6725654 ↗
• MalfunctionJun 27, 2017Break; Break

  CUSTOMER REPORTED THAT A PATIENT RECEIVED A REDO SINGLE LUMEN TPN CATHETER ON AN UNSPECIFIED DATE. THE CUSTOMER REPORTED THAT THE CENTRAL LINE IS "ABOUT TO BREAK". PEDIATRIC SURGERY WAS CALLED AND THE LINE WAS REPAIRED AT BEDSIDE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION TO ADDRESS THIS EVENT. THE CIRCUMSTANCES AND HANDLING CONDITIONS THAT LEAD UP TO THE EVENT ARE NOT KNOWN. THE DEVICE IS STILL IN CLINICAL USE, ACCORDINGLY IT IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6670050 ↗
• InjuryJun 9, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A REDO SINGLE LUMEN TPN CATHETER " BROKE DOWN BECAUSE OF TRACTION." AN ATTEMPT TO REPAIR THE DEVICE WAS NOT SUCCESSFUL; THE TIP OF THE DEVICE RUPTURED. THE PATIENT WILL REQUIRE AN EXPLANT AND REPLACEMENT OF THE DEVICE. IT IS NOT KNOWN IF THE EXPLANT AND REPLACEMENT WAS PERFORMED. NO FURTHER EVENT OR PATIENT DETAILS WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6629478 ↗
• InjuryApr 17, 2015Fluid/Blood Leak; Hole In Material

  AFTER CONNECTING AN INFUSION PUMP TO A LONG TERM CVC LINE ON (B)(6) 2015 ON A (B)(6) FEMALE PT. THE PHYSICIAN NOTICED SWELLING WHERE THE LINE IS TUNNELED THE NEXT MORNING. THE INFUSION WENT TO THE TISSUES. THE PHYSICIAN TOOK THE LINE OUT AND EXAMINED THE CATHETER. THERE WERE NO VISIBLE HOLES IN THE DEVICE WHEN THE CATHETER WAS FLUSHED. IT WORKED WELL WITH NO SIGNS OF LEAKAGE. THE PHYSICIAN THEN PUT A CLAMP AT THE TIP OF THE CATHETER TO CLOSE IT AND INJECTED SALINE IN THE CATHETER. THIS TIME THEY SAW THAT THE SALINE COMING OUT FROM 2 SMALL HOLES ON THE CATHETER. THE SWELLING HAS BEEN ABSORBED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT UNDERWENT GENERAL ANESTHESIA FOR PLACEMENT OF ANOTHER CVD LINE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Reinfusion; Surgical procedure, additional; Swelling

  MAUDE report 4713513 ↗