Dawson Mueller G51595Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002515956), received between Nov 9, 2017 and Aug 13, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Difficult to Remove; Difficult to Remove

  IN ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT NO DIFFICULTY WAS EXPERIENCED WHEN ADVANCING THE TROCAR THROUGH THE METAL CANNULA OR CATHETER DURING THE ASSEMBLY. IT WAS ALSO CONFIRMED THAT THERE WAS NO DIFFICULTY ADVANCING THE CANNULA THROUGH THE CATHETER DURING ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798401 ↗
• MalfunctionMay 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER SEPARATED AT THE SHAFT. A PLEURAL DRAIN WAS PLACED IN THE PATIENT'S RIGHT PLEURAL CAVITY ON (B)(6) 2025 AND REMAINED IN SITU AS OF (B)(6) 2025 AT 12:00 PM. LATER THAT AFTERNOON, THE PATIENT GOT UP AND EXPERIENCED A FALL, DURING WHICH THE DRAIN SNAPPED. THE WOUND WAS OBSERVED LATER THAT EVENING, REVEALING THAT THE DRAIN HAD SEPARATED AT THE SHAFT, APPROXIMATELY 3¿4 CM FROM ITS "BASE". THERE WAS NO DETACHMENT NOTED FROM THE BASE. THE BROKEN CATHETER WAS DISCARDED. 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 22064344 ↗
• MalfunctionMar 11, 2025Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

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

  Patient problems: Discomfort

  MAUDE report 21572698 ↗
• MalfunctionSep 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HUB FROM AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER SEPARATED. THE CATHETER WAS PLACED WITHOUT COMPLICATION AND WAS SECURED WITH THE SUPPLIED DRESSING. AFTER THE PROCEDURE, THE PATIENT RETURNED FROM THE CLINIC TO THE HOSPITAL WARD. LATER, SEPARATION OF THE HUB WAS DISCOVERED. THE RADIOLOGIST AND NURSE ATTENDED TO THE PATIENT AT BEDSIDE, AND THE CATHETER WAS IMMEDIATELY REMOVED. 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176260 ↗
• MalfunctionJun 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE HUB OF AN 'ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER' WAS FOUND TO BE LEAKING PRIOR TO USE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. 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 19459189 ↗
• MalfunctionNov 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE HUB OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS SEPARATED FROM THE TUBING. IT WAS NOTICED UPON OPENING THE PACKAGING. A NEW DRAINAGE CATHETER WAS USED TO COMPLETE THE PROCEDURE. 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 12807254 ↗
• MalfunctionMar 27, 2020Leak/Splash; 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 9887912 ↗
• MalfunctionJan 6, 2020Material Separation; Material Separation

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED THE PLACEMENT OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR AN UNKNOWN PROCEDURE. THE OPERATOR REPORTED THAT UPON OPENING THE PACKAGE "THE PROXIMAL TIP OF THE DRAINAGE CATHETER WAS BROKEN." THIS OCCURRED PRIOR TO PATIENT CONTACT. 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 9554631 ↗
• MalfunctionAug 29, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS ORIGINALLY REPORTED 10 UNOPENED DEVICES FAILED THE TABLE TOP LEAK TEST, HOWEVER ONLY 9 DEVICES FAILED THE LEAK TEST.

  Patient problems: No Patient Involvement

  MAUDE report 8945988 ↗
• MalfunctionAug 8, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  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 8874053 ↗
• MalfunctionAug 8, 2019Leak/Splash; 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 8873610 ↗
• MalfunctionFeb 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS USED IN AN UNKNOWN PATIENT FOR AN ASCITIC TAP PROCEDURE. THE USER REPORTED AFTER LOCKING THE DEVICE, BLOOD WAS OBSERVED LEAKING FROM THE HUB OF THE MAC-LOC NEAR THE SUTURE STRING. THE USER REMOVED THE DEVICE AND COMPLETED THE PROCEDURE WITH AN UNKNOWN DEVICE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8347862 ↗
• InjurySep 10, 2018Material Perforation; Material Perforation

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 7859928 ↗
• MalfunctionMar 6, 2018Difficult to Remove; Difficult to Remove

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHILE THE RADIOLOGIST WAS PERFORMING AN ABDOMEN ASCITES DRAINAGE PROCEDURE USING AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER, THE OUTER CANNULA OF THE METAL STIFFENER COULD NOT BE REMOVED, WHICH PREVENTED THE PLACEMENT OF THE CATHETER OVER THE WIRE. THE METAL STIFFENER HAD BEEN PLACED INTO THE CATHETER IN PREPARATION FOR AN OVER THE WIRE PLACEMENT, AND THE INTERNAL STYLET COULD BE REMOVED, BUT THE OUTER CANNULA WAS STUCK. THE USER COMPLETED THE PROCEDURE USING ANOTHER CATHETER, WITH NO FURTHER ISSUES REPORTED. THE CUSTOMER CONFIRMED THAT NO PATIENT ADVERSE EVENTS RESULTED FROM THE PRODUCT PROBLEM, AND NO ADDITIONAL PROCEDURES WERE NECESSITATED. THE COMPLAINT DEVICE HAS BEEN RETURNED; HOWEVER, AS OF THE DATE OF THIS REPORT, INVESTIGATION AND THE EVALUATION ARE STILL IN PROGRESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7317825 ↗
• MalfunctionNov 9, 2017Difficult to Remove

  IT WAS NOTED THAT THE DEVICE WAS USED FOR PARACENTESIS AND THE DEVICE WAS IN PLACE FOR "SECONDS" WHEN THE PROBLEM OCCURRED. THE COMPLAINANT REPORTED THAT THIS PRODUCT PROBLEM OCCURRED WHEN THE CATHETER WAS IN CONTACT WITH THE PATIENT'S BODY AND THE DOCTOR TRIED TO REMOVE THE CANNULA. THE CANNULA WOULD NOT RELEASE FROM THE CATHETER AND THE CATHETER WOULD CRINKLE UP ON THE CANNULA. THIS MALFUNCTION HAPPENED TWICE DURING THE SAME PROCEDURE WITH DEVICES FROM THE SAME LOT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DEVICE FROM A DIFFERENT LOT. THERE WERE NO REPORTS OF ANY SECTION OF THE DEVICE REMAINING INSIDE THE PATIENT'S BODY OR ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS PRODUCT PROBLEM. ADDITIONALLY, THE INITIAL REPORTER NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7016115 ↗