Cook G05777Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002057777), received between Sep 21, 2017 and Nov 15, 2024 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Unraveled 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Unraveled Material; Unraveled Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694498 ↗
• MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128806 ↗
• MalfunctionJul 10, 2024Unraveled Material; Unraveled Material

  IN ADDITIONAL INFORMATION RECEIVED ON 17JUL2024, IT WAS REPORTED THAT THE WIRE GUIDE WAS NOT WITHDRAWN OR MANIPULATED THROUGH THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712489 ↗
• MalfunctionMar 27, 2024Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS CLARIFIED THAT THE DRAIN WAS NOT DAMAGED. THE DRAIN PORTION OF THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988000 ↗
• InjuryMar 26, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE GUIDEWIRE OF A THAL-QUICK CHEST TUBE SET SEPARATED. DURING PLACEMENT OF A THORACIC DRAIN, THE GUIDEWIRE BECAME STUCK IN THE DRAINAGE CATHETER AND COULD NOT BE REMOVED. THE USER ATTEMPTED TO REMOVE THE GUIDE AND DRAIN TOGETHER WHEN THE GUIDE BROKE OFF INSIDE THE DRAIN. A THORACIC SURGEON PERFORMED A SURGICAL EXCISION AT THE BEDSIDE IN ORDER TO REMOVE THE PIECE OF GUIDEWIRE THAT HAD BROKEN OFF WHEN THE GUIDE WAS REMOVED. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18982808 ↗
• MalfunctionJan 19, 2024Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  IT WAS REPORTED THAT THE WIRE GUIDE FROM TWO THAL-QUICK CHEST TUBE SETS UNRAVELED DURING A CHEST TUBE INSERTION PROCEDURE. AFTER PLACING THE CATHETER OVER THE WIRE GUIDE AND INTO THE PATIENT, THE WIRE GUIDE WAS DIFFICULT TO REMOVE. AS A RESULT, BOTH THE WIRE GUIDE AND CATHETER WERE REMOVED FROM THE PATIENT. AT THIS TIME IT WAS NOTED THE WIRE GUIDE HAD "FRAYED". THE CATHETER WAS THEN REINSERTED TO COMPLETED THE PROCEDURE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18547157 ↗
• InjuryFeb 23, 2023Use of Device Problem; Use of Device Problem

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

  Patient problems: Internal Organ Perforation

  MAUDE report 16428503 ↗
• MalfunctionDec 16, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS INITIALLY REPORTED THAT A WIRE GUIDE FROM A COOK THAL-QUICK CHEST TUBE SET WAS COILED AND KINKED WHEN IT WAS OPENED. A NEW COOK THAL-QUICK CHEST TUBE SET WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED TO COOK FOR INVESTIGATION AND FOREIGN MATTER WAS PRESENT ON THE WIRE GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15997012 ↗
• MalfunctionApr 6, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN OPENING A COOK THAL-QUICK CHEST TUBE SET IN THE INTENSIVE CARE UNIT (ICU), 'RUST COLOURED' DISCOLORATION ON THE DISTAL END OF THE GUIDE WIRE LOCATED UNDER THE RED INTRODUCER WAS IDENTIFIED. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT USING ANOTHER COOK THAL-QUICK CHEST TUBE DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14025762 ↗
• InjuryFeb 14, 2019Material Separation; Material Separation

  IT WAS REPORTED IN ADDITIONAL INFORMATION RECEIVED ON 24FEB2019 THAT A 10ML SYRINGE WAS ATTACHED TO THE NEEDLE AT THE TIME OF THE EVENT. A LUER LOCK WAS NOT BEING USED. ALTHOUGH IT WAS UNCLEAR HOW MUCH OF THE NEEDLE WAS EXPOSED OUTSIDE OF THE BODY, IT WAS ESTIMATED THAT MAYBE IT WAS A COUPLE OF CENTIMETERS. THE PATIENT IS CURRENTLY RECOVERING AFTER SURGERY.

  Patient problems: No Code Available

  MAUDE report 8340961 ↗
• MalfunctionSep 26, 2017Crack; Crack

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A CHEST DRAIN INSERTION PROCEDURE, THE OPERATOR OF THE DEVICE CHECKED THE TIP OF THE DILATOR CONTAINED IN THE THAL-QUICK CHEST TUBE SET AND DISCOVERED THAT THE DISTAL TIP OF THE DEVICE WAS SNAPPED. THE OPERATOR PERFORMED THE CHECK BY TAPPING THE TIP WITH THEIR FINGER. THE TIP HAD NOT DISENGAGED, BUT THERE WAS A CRACK WHICH RAN THE CIRCUMFERENCE OF THE DILATOR. THE BROKEN DILATOR WAS RETAINED, ANOTHER SET WAS OPENED, AND THE PROCEDURE CONTINUED. THE PRODUCT IS REPORTEDLY AVAILABLE TO BE RETURNED; HOWEVER, AS OF THE DATE OF THIS REPORT, NO PRODUCT HAS YET BEEN RECEIVED FOR EVALUATION. THE DILATOR DID NOT COME INTO CONTACT WITH THE PATIENT; ACCORDINGLY, NO PATIENT ADVERSE EVENTS WERE EXPERIENCED.

  Patient problems: No Patient Involvement

  MAUDE report 6894592 ↗
• MalfunctionSep 21, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE DILATOR PORTION OF A THAL-QUICK CHEST TUBE SET BROKE DURING A DILATION PROCEDURE. AFTER THE BREAK WAS IDENTIFIED, THE OPERATOR OPTED TO USE A DILATOR FROM A DIALYSIS CATHETER INSTEAD, AND WAS ABLE TO COMPLETE THE DRAINAGE PROCEDURE SUCCESSFULLY. THE PATIENT REPORTEDLY DID NOT REQUIRE ANY ADDITIONAL PROCEDURES, AND DID NOT EXPERIENCE AND ADVERSE EVENTS AS A RESULT OF THE ISSUE. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE ARE NOT KNOWN. THE PRODUCT WAS RETURNED; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6882062 ↗