Cook G06348Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002063488), received between Jun 7, 2018 and Mar 14, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• InjuryMar 14, 2023Break; Break

  ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER ON 14MAR2023. THE COOK THAL-QUICK ABSCESS DRAINAGE CATHETER WAS SUTURED AT THE SKIN SITE, AS USUAL DRAIN PROCEDURE. GAUZE AND TAPER WERE APPLIED OVER THE ACCESS/SUTURE SITE. A COMPETITOR'S CATHETER DRAINAGE BAG WAS ATTACHED TO THE END OF THE CATHETER. AFTER THE COOK THAL-QUICK ABSCESS DRAINAGE CATHETER BROKE, THE PATIENT HAD TO ENDURE AN UNNECESSARY PROCEDURE TO REPLACE THE CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 16537979 ↗
• InjuryMar 14, 2023Break; Break

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

  Patient problems: Insufficient Information

  MAUDE report 16537978 ↗
• InjuryMar 12, 2021Break; Break

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: Insufficient Information; Pneumothorax

  MAUDE report 11475557 ↗
• InjuryMar 12, 2021Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 31MAR2021. THE DEVICE WAS PLACED FOR "ASCITES OR FLUID". NO FORCE WAS EXERTED ON THE CATHETER. A COMPETITOR DEVICE WAS ATTACHED TO THE CHEST TUBE. THE INPATIENT EXPERIENCED PROLONGED HOSPITAL STAY DUE TO COMPLICATIONS AS A RESULT OF THE EVENT. THEY ALSO DEVELOPED A PNEUMOTHORAX AS "AIR WAS SUCKED INTO THE LUNGS" AND REQUIRED DEVICE REMOVAL AND REPLACEMENT USING THE DEVICE REPORTED UNDER MDR REF. # 1820334-2021-00932. THE DEVICE WAS SAID TO HAVE SEPARATED AT THE "FIXED POSITION".

  Patient problems: Insufficient Information; Pneumothorax

  MAUDE report 11475555 ↗
• InjuryMar 11, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11468051 ↗
• MalfunctionFeb 22, 2021Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

  ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATES THE PROCEDURE WAS A DRAIN CHANGE OVER THE WIRE IN AN ABDOMINAL ABSCESS. NO ADVERSE EFFECTS OR PORTIONS OF THE DEVICE REMAINED IN THE PATIENT. ADDITIONALLY, THE WIRE USED WAS NOT A WIRE INCLUDED IN THE SET. THE CUSTOMER ONLY RETURNED TWO SPLIT DILATORS, NO WIRE GUIDE WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 11362001 ↗
• MalfunctionJun 7, 2018Material Separation; Material Separation

  IT WAS REPORTED A THAL-QUICK ABSCESS DRAINAGE CHEST TUBE CAME APART. THE TUBE WAS PLACED FOR LEFT PLEURAL EFFUSION AND THE CT JOIN CAME APART TWO DAYS AFTER. THE SURGICAL TEAM TOOK X-RAYS, MODIFIED THE CT CONNECTION AND REPORTED THE PATIENT TO BE STABLE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7578874 ↗