Cook G02727Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002027275), received between Mar 16, 2017 and Sep 9, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2019Crack; Leak/Splash; Crack; Leak/Splash

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8976855 ↗
• MalfunctionJul 20, 2017Detachment Of Device Component; Leak/Splash; Detachment Of Device Component; Leak/Splash

  CUSTOMER REPORTED THAT A PATIENT UNDERWENT A CHEST TUBE PLACEMENT WITH A LUER LOCK PLASTIC ADAPTER ON AN UNSPECIFIED DATE. THE LUER LOCK PLASTIC ADAPTER REPORTEDLY SEPARATED ALLOWING AN AIR LEAK. IT IS NOT KNOWN IF THIS EVENT OCCURRED DURING INITIAL PLACEMENT OF A CHEST TUBE OR AT A TIME FOLLOWING PLACEMENT. A DESCRIPTION OF THE CIRCUMSTANCES AND PATIENT ACTIVITIES SURROUNDING THE EVENT WAS NOT PROVIDED. THE CUSTOMER REPORTS THAT THE EVENT MAY HAVE RESULTED IN A "POSSIBLE INCREASED HOSPITAL STAY;" NO SPECIFIC DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED; NO FURTHER INFORMATION WAS RECEIVED AS OF THE DATE OF THIS REPORT. A FOLLOWUP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727972 ↗
• InjuryMar 16, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED THAT THE LUER LOCK SEPARATED FROM THE DRAINAGE ADAPTOR DURING PLACEMENT OF A CHEST TUBE. THE HANDLING CIRCUMSTANCES AND CONDITIONS SURROUNDING THE EVENT ARE NOT KNOWN. THE EVENT CAUSED AN AIR LEAK WHICH RESULTED IN AN EXTENDED HOSPITAL STAY. THERE WAS NO DIRECT PATIENT HARM OR ADVERSE PATIENT CONSEQUENCE. NO FURTHER INFORMATION WAS PROVIDED. THE ACTUAL DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6410571 ↗