Cook TPN G29464Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002294646), received between Jun 2, 2016 and Aug 31, 2017 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Hole In Material” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2017Fracture; Fracture

  THE TIP OF THE WIRE BROKE WHEN THE SURGEON WAS TAKING THE PRODUCT OUT OF THE PACKAGING . PRIOR TO PATIENT CONTACT. IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT, DURING THE REMOVAL OF THE PRODUCT FROM THE PACKAGING, THE TIP OF THE WIRE BROKE. THE CUSTOMER HAS CONFIRMED THAT THIS WAS PRIOR TO PATIENT CONTACT; ACCORDINGLY, NO ADVERSE EVENTS WERE EXPERIENCED BY THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6834637 ↗
• MalfunctionAug 3, 2017Bent; Break; Kinked; Inadequacy of Device Shape and/or Size; Device Slipped; Unraveled Material; Physical Resistance

  THE CUSTOMER REPORTED THAT "THE WIRE WAS VERY SHORT, MAKING IT VERY EASY TO DISPLACE AND NEARLY CAUSING IT TO SLIP OUT OF THE PUNCTURE POINT". IN ADDITION, THE CUSTOMER REPORTED THAT "THE MATERIAL OF THE WIRE WAS VERY FRAGILE, RESULTING IN KINKING AND UNRAVELING DURING INSERTION, AND THAT THE TIP OF THE DILATOR WAS BENDING AND BREAKING WHENEVER RESISTANCE WAS ENCOUNTERED". NO PIECES OF THE DEVICE WERE LEFT IN THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6764909 ↗
• MalfunctionMay 30, 2017Hole In Material; Hole In Material

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT RETURNED AT AN UNSPECIFIED TIME FOLLOWING INITIAL IMPLANT FOR A CATHETER EXCHANGE DUE TO A HOLE FOUND IN THE LINE (1820334-2017-01283.) THE PHYSICIAN EXCHANGED THE CATHETER AND OBSERVED A SIMILAR HOLE ON THE REPLACEMENT DEVICE (1820334-2017-01266.) THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT. NO UNINTENDED SECTION OF THE DEVICE REMAINED WITHIN THE PATIENT'S BODY. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6597783 ↗
• InjuryMay 30, 2017Hole In Material; Hole In Material

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT HAD A REDO DOUBLE LUMEN TPN CATHETER IMPLANTED. THE PATIENT RETURNED AT AN UNSPECIFIED TIME FOLLOWING INITIAL IMPLANT FOR A CATHETER EXCHANGE DUE TO A HOLE FOUND IN THE LINE. THE PHYSICIAN EXCHANGED THE CATHETER AND OBSERVED A SIMILAR HOLE ON THE REPLACEMENT DEVICE (1820334-2017-01266). THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT. NO UNINTENDED SECTION OF THE DEVICE REMAINED WITHIN THE PATIENT'S BODY. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6597760 ↗
• InjuryJun 2, 2016Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  DURING THE FLUSHING OF THE LINE THE PATIENT FELT A POP FOLLOWED BY SOME PAIN IN THE NECK. A LINOGRAM SHOWED LEAKING OF CONTRAST FROM THE LINE DUE TO A SMALL HOLE IN THE LINE. THE LINE WAS REMOVED AND A PICC LINE INSERTED INSTEAD. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5694366 ↗