Cook TPN G01868Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002018686), received between Jun 7, 2017 and May 24, 2019 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2019Material Separation; Material Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8639678 ↗
• MalfunctionJun 11, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE HUB WAS SEPARATING FROM THE CLEAR SLEEVE OF THE SINGLE LUMEN CATHETER. IT WAS LATER NOTED THAT THE SILICONE ADHESIVE SEAL WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7587829 ↗
• InjuryNov 10, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE COOK TPN SINGLE LUMEN CATHETER REPAIR SET FAILED TO REPAIR THE PATIENT'S CENTRAL VENOUS CATHETER AND BROKE. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE DEVICE ARE NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN.

  Patient problems: No Code Available

  MAUDE report 7018371 ↗
• MalfunctionSep 28, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE PART OF THE COOK TPN SINGLE LUMEN CATHETER REPAIR SET "WHICH IS NORMALLY CONNECTED WITH THE REST OF THE INTERNAL PART, NAKED ITSELF" [SIC]. THE PATIENT REPORTEDLY DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE PRODUCT FAILURE. THE CONDITIONS SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE NOT KNOWN. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. THIS WAS A PEDIATRIC PATIENT.

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

  MAUDE report 6902224 ↗
• InjurySep 27, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE PART OF THE COOK TPN SINGLE LUMEN CATHETER REPAIR SET "WHICH IS NORMALLY CONNECTED WITH THE REST OF THE INTERNAL PART, NAKED ITSELF" [SIC]. THE CUSTOMER CONFIRMED THAT, AS A DIRECT RESULT OF THE PRODUCT PROBLEM, THE OPERATOR HAD TO CHANGE OUT THE DEVICE. ADDITIONALLY, THE PEDIATRIC PATIENT EXPERIENCED BLEEDING AND REQUIRED ANTIBIOTHERAPY. THE CONDITIONS SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE NOT KNOWN. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6897171 ↗
• MalfunctionSep 11, 2017Peeled/Delaminated; Peeled/Delaminated

  THE INTERNATIONAL CUSTOMER REPORTED THAT, ON (B)(6) 2017, A COOK TPN SINGLE LUMEN CATHETER REPAIR SET WAS EMPLOYED TO REPAIR A CENTRAL VENOUS CATHETER OF UNSPECIFIED MANUFACTURE. APPROXIMATELY 48 HOURS LATER, ON (B)(6), 2017, THE REPAIR KIT BEGAN TO PEEL OFF. THE RUPTURE WAS ONLY OF THE OUTER MEMBRANE; THE INNER MEMBRANE REMAINED INTACT, BUT IT WAS NECESSARY TO REPAIR IT A SECOND TIME. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE DEVICE ARE NOT FULLY KNOWN. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PRODUCT IS REPORTEDLY AVAILABLE FOR EVALUATION, BUT AS OF THE DATE OF THIS REPORT THE DEVICE HAS NOT YET BEEN RETURNED. IT WAS LATER REPORTED IN A RESPONSE TO A FOLLOW UP REQUEST FOR ADDITIONAL INFORMATION THAT THE PATIENT WAS 2 YEARS OLD, AND THIS DEVICE WAS USED TO REPAIR THE LEAKING COMPLAINT DEVICE WHICH IS THE SUBJECT OF MDR REPORT # 1820334-2017-02634.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6854666 ↗
• InjuryJun 7, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT THE LUMEN OF A COOK TPN SINGLE LUMEN CATHETER REPAIR SET CRACKED AT AN UNSPECIFIED TIME FOLLOWING INITIAL IMPLANT. THE HANDLING CONDITIONS AND CIRCUMSTANCES SURROUNDING THE EVENT ARE NOT KNOWN. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER IT HAD NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 6617363 ↗