Cook TPN G07933Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002079335), received between Aug 29, 2016 and Nov 19, 2020 — classified as 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN ADDITIONAL INFORMATION RECEIVED ON 25NOV2020, IT WAS REPORTED THAT ANTIBIOTICS WERE USED TO TREAT THE OCCURRENCE OF SEPSIS. THE ONLY PRE-EXISTING CONDITION THAT WOULD HAVE MADE THE PATIENT PRE-DISPOSED FOR TO A HIGHER RISK OF INFECTION WAS SHORT BOWEL SYNDROME. THE PATIENT WAS DESCRIBED AS SELF CARING AT THE TIME SEPSIS OCCURRED. THE DEVICE WAS PLACED IN THE LEFT INTERNAL JUGULAR FOR TPN ADMINISTRATION. THE FAILURE OCCURRED DURING TREATMENT. WHEN NOT IN USE, THE CATHETER WAS FLUSHED WITH AND LOCKED AN 0.9% SALINE SOLUTION. A PRESUMED 10ML SYRINGE WAS USED FOR FLUSHING. A NEEDLELESS INJECTOR CAP WAS USED, HOWEVER NO ANTI-TAMPER DEVICE WAS USED. THE DEVICE WAS INITIALLY SECURED WITH SUTURES, HOWEVER GRIPLOK WAS LATER USED. PATIENT ACTIVITY LEVEL WAS DESCRIBED AS "ACTIVE."

  Patient problems: No Code Available; Sepsis

  MAUDE report 10868375 ↗
• InjuryNov 4, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A REDO SINGLE LUMEN TPN CATHETER HAS SPLIT. THE PATIENT HAS REPORTEDLY GONE THROUGH "SEVERAL" LINES AND HAS PRESENTED WITH A SPLIT LINE TWICE IN (B)(6) 2020. THE SECOND SPLIT IS ALSO REPORTED UNDER AN MDR WITH PATIENT IDENTIFIER (B)(6). DUE TO THIS OCCURRENCE, IT WAS REPORTED THE PATIENT REQUIRED "MORE VENOUS INTERVENTION" AND X-RAY IMAGING. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED BUT IS NOT CURRENTLY AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10786389 ↗
• InjuryFeb 28, 2020Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE SEAL AROUND THE WHITE HUB OF A REDO SINGLE LUMEN TPN CATHETER SET WAS FOUND TO BE PARTIALLY BROKEN AWAY AFTER PLACEMENT. CONSEQUENTLY, THE HUB IS ABLE TO BE MOVED. THE LINE WAS INSERTED ON (B)(6) 2019. ON THE AFTERNOON OF (B)(6) 2020, THE PATIENT CAME INTO THE HOSPITAL FOR REVIEW. THE NURSE SAW THAT THE SEAL AROUND THE HUB WAS PARTIALLY BROKEN AWAY, IN WHICH THE WHITE HUB WAS ABLE TO BE MOVED. ULTIMATELY THE PATIENT'S LINE WAS REPLACED ON (B)(6) 2020. THE PATIENT REPORTEDLY HAD PREVIOUS ISSUES IN THE PAST WITH THE SAME DEVICE. THIS WAS CAPTURED IN MFG. REPORT REFERENCE #: 1820334-2020-00500. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9770487 ↗
• InjuryJan 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A SINGLE LUMEN TPN CATHETER SET RUPTURED. TEMPORARY HEMODYNAMIC DESTABILIZATION OCCURRED IN THE PATIENT DUE TO THE INTERRUPTED DELIVERY OF INOTROPIC DRUGS. THE CATHETER WAS REMOVED AND A CENTRAL LINE WAS PLACED EMERGENTLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED RELATED TO THE PLACEMENT OF THE DEVICE, EVENT, CATHETER MAINTENANCE, AND ACTIVITY LEVEL OF PATIENT BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Code Available; Vascular System (Circulation), Impaired

  MAUDE report 9612840 ↗
• InjurySep 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION REGARDING AN UPDATED CUSTOMER COMPLAINT FORM WAS RECEIVED ON 31OCT2019. IT WAS REPORTED THAT THE DEVICE WAS "PLACED IN PATIENT IN IR". IT WAS ALSO REPORTED THAT THE PATIENT WAS BACK ON THE WARD WHEN THE LINE BROKE OFF. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 9124988 ↗
• InjuryJun 15, 2018Material Separation; Material Separation

  IT WAS REPORTED A PATIENT HAD A REDO SINGLE LUMEN TPN CATHETER INSERTED ON (B)(6) 2017. THE LINE LOOKED INFECTED AND THEREFORE WAS REMOVED ON (B)(6) 2017. THE PATIENT RETURNED TO THE FACILITY ON (B)(6) 2017 WITH AN ABSCESS. AN EXPLORATORY AND ABSCESS DRAINAGE PROCEDURE FOUND A PART OF THE LINE, DACRON CUFF, HAD BEEN LEFT IN THE SURGICAL SITE AND WAS REMOVED.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7606020 ↗
• MalfunctionSep 26, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT, FOLLOWING PLACEMENT OF THE DEVICE ON (B)(6) 2017, THE REDO SINGLE LUMEN TPN CATHETER "APPEARS FISSURED IN THE PART WHERE IT NARROWS" [SIC]. THE EVENT WAS ALSO TRANSLATED AS " CVC RUPTURE - IT APPEARS SPLIT WHERE IT SHRINKS" [SIC]. THE CATHETER REPORTEDLY RUPTURED ALONG A NARROW AREA OF THE DEVICE. NO ADDITIONAL PROCEDURES WERE ALLEGEDLY REQUIRED AS A RESULT OF THIS ISSUE, AND NO PATIENT ADVERSE EFFECTS WERE REPORTED. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO PRODUCT HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6894175 ↗
• MalfunctionSep 14, 2017Hole In Material; Hole In Material

  IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT, WHEN PLACING THE REDO SINGLE LUMEN TPN (TOTAL PARENTERAL NUTRITION) CATHETER, A HOLE WAS NOTICED PROXIMAL TO THE SUTURE AREA OF THE DEVICE. THE CUSTOMER FURTHER REPORTED THAT THE ISSUE DID NOT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES, AND NO PATIENT ADVERSE EFFECTS WERE REPORTED. THE PRODUCT IS REPORTEDLY RETURNING; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6866182 ↗
• MalfunctionAug 9, 2017Device Damaged Prior to Use; Device Damaged Prior to Use

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS SCHEDULED FOR A NEPHROSTOMY PROCEDURE. THE CUSTOMER REPORTS THAT THE TIP OF THE REDO SINGLE LUMEN TPN CATHETER BROKE. THE EVENT OCCURRED DURING DEVICE EXAMINATION PRIOR TO USE ON THE PATIENT. A REPLACEMENT CATHETER WAS OBTAINED TO COMPLETE THE PROCEDURE THERE ARE NO REPORTS OF ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 6777538 ↗
• InjuryJul 3, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT RECEIVED A REDO SINGLE LUMEN TPN CATHETER FOR TREATMENT OF LEUKEMIA. THE CUSTOMER REPORTED THAT THE CATHETER BROKE 'INVOLUNTARILY' AT AN UNSPECIFIED TIME FOLLOWING INITIAL PLACEMENT. THE EVENT OCCURRED AT THE HOME OF THE PATIENT. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

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

  MAUDE report 6683953 ↗
• MalfunctionJun 9, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A REDO SINGLE LUMEN TPN CATHETER " BROKE DOWN BECAUSE OF TRACTION." NO FURTHER EVENT OR PATIENT DETAILS WERE PROVIDED. THERE IS NO INDICATION OF ANY ADVERSE PATIENT CONSEQUENCE. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING TO THE EVENT WERE NOT PROVIDED. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION; NO ADDITIONAL INFORMATION WAS PROVIDED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6629220 ↗
• MalfunctionFeb 23, 2017Hole In Material; Hole In Material

  THE CUSTOMER REPORTED THAT THE PREVIOUSLY REPAIRED SINGLE LUMEN TPN CATHETER BROKE. THIS DEVICE WAS INITIALLY IMPLANTED ON (B)(6) 2016. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE ON 12/16/2016 TO REMOVE AND REPLACE THE BROKEN CATHETER. THIS EVENT WAS PREVIOUSLY REPORTED IN MDR# 1820334-2017-00006. DURING THE PRELIMINARY INVESTIGATION OF THE BROKEN CATHETER, IT WAS NOTED THAT THERE WAS A HOLE IN IT THAT WAS NOT RELATED TO THE PREVIOUSLY REPORTED BREAK. A HOLE WAS FOUND IN THE CATHETER SEPARATE FROM AND NOT RELATED TO THE PREVIOUSLY REPORTED BREAK. THE CIRCUMSTANCES, CONDITIONS AND ETIOLOGY OF THIS HOLE IN THE MATERIAL IS NOT KNOWN. THE PRESENCE OF THIS OBSERVED HOLE HAS THE POTENTIAL TO RESULT IN A LEAK FROM THE DEVICE. THIS REPORT IS TO CAPTURE THE MALFUNCTION OF THE HOLE NOT PREVIOUSLY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6352661 ↗
• InjuryJan 17, 2017Fracture; Fracture

  INTERNATIONAL CUSTOMER REPORTED THAT A PREVIOUSLY REPAIRED CATHETER BROKE. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO REMOVE AND REPLACE THE BROKEN CATHETER. NO FURTHER EVENT DETAILS WERE PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6255616 ↗
• InjuryNov 7, 2016Material Separation; Material Separation

  THE CUSTOMER HAD INFORMED THE SALES REPRESENTATIVE THAT EVERY 6TH CATHETER HAD BROKEN. UPDATE INFORMATION PROVIDED ON (B)(6) 2016 STATED A NEW ONE (PRODUCT) WAS INSERTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED BY THE REPORTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6083036 ↗
• InjuryOct 25, 2016Leak/Splash; Leak/Splash

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

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 6053431 ↗
• InjuryAug 29, 2016Material Separation; Material Separation

  IT WAS REPORTED DURING A TOTAL PARENTERAL NUTRITION (TPN) PLACEMENT PROCEDURE FOR A (B)(6) FEMALE PATIENT, THE CUFF "POPPED OFF" AND WAS RETRIEVED WITHOUT DIFFICULTY. REPORTEDLY TWO DEVICES FAILED AND THE THIRD WAS SUCCESSFULLY USED, IT IS UNCLEAR IF THE TWO FAILURES WERE THE SAME ISSUE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THIS REQUIRED AN ADDITIONAL PROCEDURE FOR PLACEMENT OF ANOTHER TPN. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5910551 ↗