Dawson Mueller G13765Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002137653), received between Apr 25, 2017 and Jul 1, 2024 — classified as 4 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Material Separation; Material Split, Cut or Torn; Material Separation; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO INSERT INTO THE PATIENT. THE DEVICE WAS PLACED VIA A ¿ONE STEP¿ TECHNIQUE. THERE WAS "NORMAL RESISTANCE" WHEN ADVANCING THE DEVICE OVER THE WIRE GUIDE THROUGH THE PATIENT'S SKIN, BUT RESISTANCE ADVANCING THE DEVICE INTO THE PATIENT PREVENT SUCCESSFUL PLACEMENT. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL LIKE-DEVICE. THE DEVICE WAS RETURNED TO COOK ON 24JUN2024. PRELIMINARY DEVICE FAILURE ANALYSIS NOTED THE CATHETER¿S TIP WAS SPLIT, THUS PROMPTING THIS REPORT. 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 19645834 ↗
• MalfunctionDec 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION HAS BEEN ADDED TO THE DESCRIPTION OF EVENT SINCE THE PREVIOUS MEDWATCH REPORT WAS SUBMITTED.

  Patient problems: No Patient Involvement

  MAUDE report 8160685 ↗
• MalfunctionOct 18, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED IN THE PATIENT'S BILE DUCT FOR A PERCUTANEOUS TRANSHEPATIC CHOLANGIO-DRAINAGE (PTCD) PROCEDURE. ANGIOGRAPHY WAS USED TO CONFIRM CATHETER PLACEMENT. WHEN ASPIRATION WAS PERFORMED TO VERIFY DEVICE FUNCTION, NOTHING WAS ASPIRATED. THE PHYSICIAN THEN FLUSHED THE CATHETER AND DISCOVERED LEAKAGE AROUND THE HUB. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7980095 ↗
• MalfunctionApr 25, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. ACCESS TO THE TARGET LESION WAS GAINED THROUGH A RIGHT INTERCOSTAL APPROACH. THE PHYSICIAN ATTEMPTED TO CONFIRM PROPER PLACEMENT OF THE DEVICE WITHIN THE LESION BY PLACING NEGATIVE PRESSURE WITHIN THE DEVICE TO ASPIRATE FLUID; AIR WAS ASPIRATED RATHER THAN FLUID. THE DEVICE WAS REMOVED AND A NEW DEVICE PLACED AND THE PROCEDURE COMPLETED. POST PROCEDURE TESTING BY THE PHYSICIAN OF THE DEVICE BY INJECTING SALINE IDENTIFIED A LEAK BETWEEN THE HUB AND THE CATHETER. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6519094 ↗