Cook G13355Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002133556), received between Oct 7, 2016 and Dec 21, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE ULTRATHANE EXTENDED LENGTH SIDEPORTS BILIARY DRAINAGE CATHETER BEGAN TO LEAK AT AN UNSPECIFIED TIME FOLLOWING THE SURGERY IN WHICH THE DEVICE WAS PLACED IN A PATIENT. THE PATIENT ULTIMATELY HAD TO RETURN TO SURGERY TO HAVE THE DRAIN REMOVED AND REPLACED WITH ANOTHER PRODUCT. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE LEADING UP TO THE PRODUCT PROBLEM WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN PROVIDED. THE DEVICE 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 7139542 ↗
• InjuryOct 7, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THE: "PATIENT RETURNED TO DEPT ONE DAY AFTER A BILIARY DRAIN WAS INSERTED, STAFF FOUND THE HUB WAS CRACKED. THEY REPLACED THE DRAIN WITH ANOTHER ONE OF A DIFFERENT LOT#." "PATIENT NEEDED TO RETURN TO HAVE DRAIN REPLACED". AN FDA REPORT WAS RECEIVED FROM THE USER FACILITY WHICH STATED : "DRAIN BROKE AFTER PATIENT ARRIVED HOME, PER PATIENT THEY HADN'T DONE ANYTHING UNUSUAL. FLUID STOPPED DRAINING. PATIENT NEEDED TO RETURN TO THE OPERATING ROOM FOR REPLACEMENT. FURTHER CONFIRMATION WITH THE CUSTOMER BY THE (B)(6) REPORTED "THE ISSUE WAS WHERE THE CATHETER IS CONNECTED TO THE HUB WHERE THE LUER LOCK CONNECTS ¿ IT WAS LEAKING AT THE SEAM." 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 6011596 ↗