Cook G04137Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002041370), received between Jun 7, 2019 and May 7, 2025 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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.

• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT THE WIRE GUIDE INCLUDED IN THE THAL-QUICK CHEST TUBE SET BROKE DURING ITS PERCUTANEOUS INSERTION FOR PNEUMOTHORAX IN A 46-YEAR-OLD MALE PATIENT. AS PER THE PHYSICIAN, THE WIRE GUIDE BROKE WHILE DILATING THE LESION. THE BROKEN PORTION OF THE DEVICE WAS "CLOSE TO THE SKIN (ON THE OUTSIDE), SO IT WAS EASILY RETRIEVED". AFTER THE BROKEN PORTION WAS REMOVED, THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A NEW SAME DEVICE. THE WIRE GUIDE WAS NOT MANIPULATED OR WITHDRAWN THROUGH THE NEEDLE. TORTUOUS PATIENT ANATOMY WAS DENIED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976998 ↗
• InjurySep 27, 2024Use of Device Problem; Human-Device Interface Problem; Use of Device Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT THE THAL-QUICK CHEST TUBE WAS INADVERTENTLY INSERTED INTO THE LEFT HEART OF A PATIENT DURING A CHEST TUBE PLACEMENT PROCEDURE TO RELIEVE A PLEURAL EFFUSION. A 74-YEAR-OLD MAN WITH A PAST MEDICAL HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND CACHEXIA PRESENTED TO THE EMERGENCY DEPARTMENT WITH DYSPNEA AND WEAKNESS AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR DECOMPENSATED COVID-19 PNEUMONIA. SERIAL CHEST RADIOGRAPHS REVEALED A WORSENING LEFT-SIDED PLEURAL EFFUSION. A POST GRADUATE YEAR 3 EMERGENCY MEDICINE RESIDENT PHYSICIAN ATTEMPTED PLACEMENT OF A 24 FRENCH THAL-QUICK CATHETER CHEST TUBE USING BLUNT DISSECTION AND THE SELDINGER TECHNIQUE WITH SERIAL DILATIONS AT THE THIRD INTERCOSTAL SPACE AT THE MIDAXILLARY LINE. UPON REMOVAL OF THE FINAL DILATOR FROM THE CHEST TUBE LUMEN, PULSATILE BLOOD FLOW WAS OBSERVED, AND THE CHEST TUBE WAS IMMEDIATELY CLAMPED. THE PATIENT REMAINED AWAKE, ALERT, AND RECEIVED SUPPLEMENTAL OXYGEN WITH AN SPO2 > 92% THROUGHOUT THE PROCEDURE. IMMEDIATELY THEREAFTER, HIS MEAN ARTERIAL PRESSURE DECREASED TO 58 MMHG. A CHEST X-RAY WAS PERFORMED AND SUGGESTED THE CHEST TUBE BEING IN THE LEFT HEART. THE PATIENT WAS EMERGENTLY TAKE

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 20326993 ↗
• MalfunctionJan 12, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  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 18505857 ↗
• InjuryJan 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IN ADDITIONAL INFORMATION RECEIVED ON 30JAN2024, IT WAS REPORTED THAT A CONNECTING TUBE WAS ATTACHED TO THE CATHETER AT THE TIME OF FAILURE. THE PATIENT WAS BEDBOUND, AND A SUTURE WAS USED TO SECURE THE CATHETER TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18467658 ↗
• MalfunctionJun 20, 2023Unsealed Device Packaging; Unsealed Device Packaging

  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 17164825 ↗
• MalfunctionMar 22, 2023Unraveled 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 16592195 ↗
• InjuryJan 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AFTER THE PLACEMENT OF THE COOK THAL-QUICK CHEST TUBE, IT WAS FOUND TO BE DISCONNECTED FROM THE PATIENT WHILE IN THE WARD. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER BRAND OF CHEST TUBE. A PHOTO OF THE SEPARATION WAS PROVIDED BY THE CUSTOMER SHOWING THE UNIVERSAL (FUNNEL END) OF THE CATHETER HAD SEPARATED FROM THE CATHETER SHAFT.

  Patient problems: Pneumothorax

  MAUDE report 13361182 ↗
• MalfunctionJan 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER INCLUDED IN THE THAL-QUICK CHEST TUBE SET SEPARATED FROM THE HUB. THE CHEST TUBE HAD BEEN IN PLACE FOR DRAINAGE FOR SEVEN DAYS. A DAILY DRESSING CHANGE WAS CONDUCTED IN ENDOSCOPY. UPON RETURN FROM THE WARD FOLLOWING THE LAST DRESSING CHANGE, IT WAS DISCOVERED THAT THE CATHETER WAS DISCONNECTED AT THE HUB. THE ENDOSCOPY NURSE WAS CALLED AND THE DRAIN WAS CLOSED AND THEN REMOVED AFTER ONE DAY. THE PATENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342339 ↗
• MalfunctionSep 28, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PACKAGING OF A THAL-QUICK CHEST TUBE SET WAS "STAINED". A PHOTO OF THE DEVICE REVEALED A SMALL, BLACK FOREIGN MATTER WITHIN THE SEALED PACKAGING. NO PATIENT CONTACT WAS MADE, AS THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540708 ↗
• InjuryJun 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A THAL-QUICK CHEST TUBE SET "DISCONNECTED ON PATIENT" 3 DAYS AFTER THE PROCEDURE. THERE WAS NO ISSUE PLACING THE DEVICE. NO UNINTENDED SECTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAS BEEN REQUESTED BUT IS NOT CURRENTLY AVAILABLE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10106116 ↗
• InjuryFeb 26, 2020Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem

  IT WAS REPORTED THAT THE CONNECTER OF A THAL-QUICK CHEST TUBE SET WAS FOUND BROKEN AT THE JUNCTION WITH THE DRAIN. THE DEVICE WAS PLACED IN THE PATIENT'S PLEURAL SPACE TO DRAIN A PRE-EXISTING PLEURAL EFFUSION ON (B)(6) 2020. DURING THE NIGHT FOUR DAYS AFTER PLACEMENT, THE DRAIN WAS FOUND DISCONNECTED, LEAVING IT IN THE OPEN. CONSEQUENTLY, THIS CAUSED THE PATIENT TO DEVELOP A SMALL IATROGENIC PNEUMOTHORAX, WHICH WAS CONFIRMED BY X-RAY IMAGING. PRIOR TO THIS, NO ISSUES WITH THE DEVICE WERE NOTED. FOLLOWING THIS INCIDENT, A NEW DEVICE WAS PLACED. ADDITIONAL INFORMATION REGARDING THE PATIENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Code Available; Pneumothorax

  MAUDE report 9758239 ↗
• MalfunctionJun 7, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Patient Involvement

  MAUDE report 8680291 ↗