Dawson Mueller G13766Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00827002137660), received between Sep 1, 2016 and Oct 21, 2025 — classified as 6 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  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 23350636 ↗
• MalfunctionJun 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED. THE DEVICE WAS PLACED IN THE GALLBLADDER VIA DIRECT PUNCTURE ON (B)(6) 2025. THERE WERE NO PROBLEMS DURING THE OPERATION. PER THE FACILITY'S STANDARD PROTOCOL, ALL PARTS OF THE CATHETER EXPOSED OUTSIDE OF THE BODY ARE FIXED WITH GAUZE AND COVERED WITH A DRESSING. THE CATHETER IS UNABLE TO BE SEEN UNLESS THE DRESSING IS REMOVED. THE CATHETER WAS CONNECTED TO A 10 CM CONNECTION TUBE AND DRAINAGE BAG. IT IS UNKNOWN IF THE FITTING WAS SECURELY ATTACHED AT FIRST INSPECTION. ON (B)(6) 2025, FIVE DAYS AFTER PLACEMENT, A LARGE AMOUNT OF BILE WAS LEAKING. THE DEVICE WAS CHECKED; HOWEVER, THE PHYSICIAN COULD NOT FIND THE SOURCE OF THE LEAK. THE CONNECTION BETWEEN THE CATHETER AND DRAIN BAG SEEMED LOOSE, SO THE PHYSICIAN RE-TIGHTENED IT. A FEW DAYS LATER, A SMALL AMOUNT OF BILE WAS LEAKING FROM THE JOINT BETWEEN THE DRAINAGE CATHETER AND THE HUB. ON (B)(6) 2025, WHEN THE SALES REP WENT TO THE HOSPITAL TO CHECK, THE GAUZE IN THAT AREA BETWEEN THE DRAINAGE CATHETER AND THE HUB WAS DIRTY. THE LEAK COULD NOT BE SEEN DIRECTLY. THE DRAINAGE WAS ALMOST COMPLETE, SO IT WAS DETERMINED THAT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168579 ↗
• MalfunctionMay 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IN ADDITIONAL INFORMATION RECEIVED ON 22MAY2025, IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED BY A RADIOLOGIST FOLLOWED BY CATHETER PLACEMENT BY A SURGEON. NO REQUEST FOR CATHETER REPLACEMENT WAS MADE BY THE RADIOLOGIST, AND SINCE REPLACEMENT IS UNCOMMON, IT IS LIKELY THAT THE SURGERY PROCEEDED WITHOUT CATHETER REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005698 ↗
• MalfunctionApr 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE TIP OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS FOUND TO BE SPLIT FOLLOWING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTCD) PROCEDURE FOR AN UNKNOWN PATIENT. UPON OPENING THE PACKAGE, NO DAMAGE TO THE DEVICE WAS NOTED. USING THE SELDINGER TECHNIQUE, DILATION WAS COMPLETED AND AN ATTEMPT TO ADVANCE THE DRAINAGE CATHETER WITH THE PLASTIC FLEXIBLE STIFFENING CANNULA INSERTED WAS MADE WITHOUT SUCCESS. THE COMPLAINT DEVICE WAS THEN REMOVED, AND A NEW DEVICE OF THE SAME KIND WAS SUCCESSFULLY ADVANCED INTO THE BILE DUCT. THE PATIENT DID NOT HAVE TORTUOUS ANATOMY. PATIENT ACTIVITY LEVEL REMAINS UNKNOWN. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION ON 15APR2025. DURING THE PRELIMINARY DEVICE FAILURE ANALYSIS (DFA), A SLIGHT SPLIT AT THE CATHETER'S TIP WAS OBSERVED. 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 21920883 ↗
• MalfunctionNov 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER HUB LEAKED DURING AN UNKNOWN PROCEDURE ON A PATIENT OF UNKNOWN AGE AND GENDER. THE PROCEDURE WAS COMPLETED USING ANOTHER LIKE DEVICE. AS NOTED BY THE CUSTOMER, THERE WAS NO DAMAGE TO THE PACKAGE PRIOR TO THE USE AND NO FORCE WAS EXERTED ON THE CATHETER. 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 20588189 ↗
• MalfunctionOct 22, 2024Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

  IT WAS REPORTED THAT AIR LEAKAGE WAS FOUND TO BE COMING FROM AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DURING AN UNKNOWN PROCEDURE. USAGE OF THE DEVICE WAS DISCONTINUED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER LIKE-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 20508864 ↗
• MalfunctionAug 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED ON 15AUG2024. IT WAS REPORTED THAT THE PHYSICIAN NOTED THE TEAR WHEN HE "INSERTED THE DEVICE". HOWEVER, THE DEVICE WAS NOT INSERTED INTO THE PATIENT. IT IS UNKNOWN IF THE PATIENT HAD TORTUOUS ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19944461 ↗
• MalfunctionJul 19, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE STIFFENING CANNULA OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS UNABLE TO BE REMOVED DURING A BILIARY DRAINAGE PROCEDURE ON AN UNKNOWN PATIENT. THE DRAINAGE CATHETER, STIFFENING CANNULA AND TROCAR STYLET WERE ADVANCED OVER THE WIRE GUIDE INTO THE TARGET SITE OF THE BILE DUCT FOR BILIARY DRAINAGE. THE PHYSICIAN TRIED TO REMOVE THE STIFFENING CANNULA FROM THE CATHETER BUT WAS UNABLE TO DO SO. A PRODUCT FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS NOTED THAT NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE UPON OPENING. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL INFORMATION DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17351400 ↗
• MalfunctionSep 13, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE METAL STIFFENING CANNULA WAS UNABLE TO BE REMOVED FROM THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIO-DRAINAGE PROCEDURE. THE STIFFENING CANNULA WAS INSERTED INTO THE DRAINAGE CATHETER OVER A WIRE GUIDE. THE PHYSICIAN ATTEMPTED TO REMOVE THE STIFFENING CANNULA FROM THE CATHETER AFTER ADVANCING THEM AS A UNIT TO THE TARGET SITE, HOWEVER THE CANNULA BECAME STUCK AFTER 3CM OF REMOVAL. THE CATHETER AND CANNULA WERE REMOVED FROM THE PATIENT AS A UNIT AND A COMPETITOR'S DRAINAGE CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGE. THE PRODUCT WAS STORED VERTICALLY ON A WALL HOOK. THE FIXED DISK WAS NOT USED TO SECURE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460222 ↗
• MalfunctionJan 28, 2021Gas/Air 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: No Consequences Or Impact To Patient

  MAUDE report 11248423 ↗
• MalfunctionJan 28, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR BILE DUCT DRAINAGE. IMMEDIATELY FOLLOWING PLACEMENT, WHEN THE PHYSICIAN APPLIED NEGATIVE PRESSURE, BILE LEAKED BETWEEN THE MAC-LOCK HUB AND CATHETER. THE DEVICE WAS REMOVED AND REPLACED WITH A SIMILAR DEVICE TO COMPLETE THE PROCEDURE 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 11248306 ↗
• MalfunctionAug 4, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR A DRAINAGE OF PUS IN THE BILE DUCT. DURING THE PROCEDURE, THE OPERATOR NOTED THE FLEXIBLE STIFFENER WAS DIFFICULT TO REMOVE FROM THE DRAINAGE CATHETER. THE DEVICE WAS REPLACED WITH ANOTHER SIMILAR DEVICE 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 Known Impact Or Consequence To Patient

  MAUDE report 10362153 ↗
• MalfunctionJun 10, 2020Difficult to Advance; Difficult to Advance

  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 10139038 ↗
• InjuryMar 17, 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 Code Available

  MAUDE report 9841710 ↗
• MalfunctionDec 6, 2019Difficult to Advance; Difficult to Advance

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR A BILIARY DRAINAGE PROCEDURE. THE OPERATOR REPORTS THAT AFTER PERFORMING DILATION TO THE ACCESS POINT, THEY WERE UNABLE TO INSERT THE DEVICE INTO THE PATIENT'S BODY. THE OPERATOR REPORTED AN "EQUIVALENT PRODUCT" WAS UTILIZED 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 Known Impact Or Consequence To Patient

  MAUDE report 9432341 ↗
• MalfunctionJul 31, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACE IN THE RIGHT INTRAHEPATIC BILE DUCT OF THE PATIENT FOR A PERCUTANEOUS DRAINAGE PROCEDURE. AS REPORTED, THE PHYSICIAN ATTEMPTED TO PERFORM DRAINAGE BUT "AIR WAS ASPIRATED AND DRAINAGE COULD NOT BE CONDUCTED." 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 Known Impact Or Consequence To Patient

  MAUDE report 8845126 ↗
• MalfunctionSep 17, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED INTO THE ABDOMEN OF A PATIENT DURING A DRAINAGE PROCEDURE. IT WAS NOTED THAT THE CATHETER WAS UNABLE TO DRAIN. THE DEFECTIVE DEVICE WAS REMOVED AND ANOTHER LIKE DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

  Patient problems: No Code Available

  MAUDE report 7881950 ↗
• MalfunctionJul 3, 2018Aspiration Issue; Aspiration Issue

  IT WAS REPORTED DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE (PTCD) PROCEDURE, THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WOULD NOT FUNCTION DUE TO AIR ASPIRATION. THE DEVICE WAS REMOVED AND REPLACED WITH A LIKE DEVICE FROM THE SAME LOT AND THE SAME FAILURE OCCURRED. A THIRD DEVICE FROM A DIFFERENT LOT WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 7659250 ↗
• InjuryMar 13, 2018Material Separation; Material Separation

  THE INTERNATIONAL CUSTOMER REPORTED THAT, THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS USED FOR AN PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE OF THE INTRAHEPATIC BILE DUCT. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL WARD AND WHEN THE PATIENT WAS CHECKED ON THE SAME DAY, IT WAS DISCOVERED THAT THE HUB OF THE DEVICE BECAME SEPARATED FROM THE CATHETER TUBE. THE DEVICE WAS REPLACED WITH ANOTHER DRAINAGE CATHETER. THE DEVICE HAS BEEN RETURNED; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION AND EVALUATION IS ONGOING.

  Patient problems: No Code Available

  MAUDE report 7336024 ↗
• MalfunctionNov 14, 2017Detachment Of Device Component

  IT WAS REPORTED THAT APPROXIMATELY EIGHT DAYS AFTER THE CATHETER WAS PLACED IN THE PATIENT THAT THE HUB SEPARATED FROM THE CATHETER. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7029423 ↗
• InjuryNov 13, 2017Material Separation

  THE CATHETER WAS PLACED FOR PTCD WITH NO PROBLEM. DURING PATIENT CARE VISIT, IT WAS CONFIRMED THAT THE CATHETER SEPARATED FROM THE HUB. THE CATHETER WAS REPLACED WITH ANOTHER ONE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Code Available

  MAUDE report 7026093 ↗
• InjuryNov 10, 2017Detachment Of Device Component

  AFTER PLACEMENT THE CATHETER SEPARATED FROM THE HUB THOUGH NO EXCESSIVE FORCE WAS APPLIED NOR BEING CAUGHT ON ANYTHING. THE CATHETER WAS REPLACED WITH ANOTHER ONE. THERE HAVE BEEN NO OTHER ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Code Available

  MAUDE report 7019479 ↗
• MalfunctionNov 10, 2016Material Separation; Material Separation

  IT WAS REPORTED A CATHETER THAT WAS PLACED IN THE PATIENT ON (B)(6) 2016 SEPARATED FROM THE HUB WHEN THE PATIENT TOUCHED IT. THE CATHETER WAS REPLACED WITH ANOTHER ONE ON 11 OCT 2016. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Code Available

  MAUDE report 6093981 ↗
• InjurySep 9, 2016Material Separation; Material Separation

  ON (B)(6) 2016 A CATHETER WAS PLACED IN THE PATIENT FOR A PTCD PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2016 DURING A PATIENT CARE VISIT, IT WAS FOUND THAT THE HUB HAD SEPARATED FROM THE CATHETER. THE CATHETER WAS REPLACED WITH ANOTHER ONE. THE PATIENT HAD A FAVORABLE OUTCOME.

  Patient problems: No Code Available

  MAUDE report 5939067 ↗
• MalfunctionSep 1, 2016Aspiration Issue; Aspiration Issue

  AFTER PLACEMENT OF THE CATHETER AT DESIRED LESION, THE USER ATTEMPTED NEGATIVE PRESSURE WITH SYRINGE TO CONFIRM LOCATION OF THE CATHETER, BUT ONLY AIR WAS ASPIRATED. THE COMPLAINT CATHETER WAS REMOVED FROM THE PATIENT'S BODY, AND ANOTHER DEVICE WAS USED INSTEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5920625 ↗