Dawson Mueller G27298Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00827002272989), received between Aug 1, 2016 and Jun 10, 2024 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IN ADDITIONAL INFORMATION RECEIVED ON 11JUN2024, IT WAS REPORTED THAT THE DEVICE WAS IN PLACE FOR 15 MINUTES BEFORE LEAKAGE WAS NOTED. AT THE TIME OF FAILURE, THE PATIENT WAS LYING ON THE OPERATING TABLE AND HADN'T MOVED. PATIENT ACTIVITY LEVEL WAS DESCRIBED AS "PATIENT LEVEL IS UP WITH ASSIST."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505027 ↗
• InjuryMay 4, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE CATHETER OF AN ULTRATHANE MULTIPURPOSE DRAINAGE SET WAS DIFFICULT TO REMOVE FROM AN UNKNOWN PATIENT. THE PATIENT HAD THE CATHETER PLACED WITH NO ISSUES IN THE BILE DUCT FOR PERCUTANEOUS TRANSHEPATIC CHOLANGIO-DRAINAGE. AFTER SIX DAYS OF PLACEMENT, ON (B)(6) 2023, THE CATHETER WAS REMOVED. RESISTANCE WAS EXPERIENCED AND THE PATIENT "FELT HURT" WHEN REMOVING THE CATHETER. THE USER NOTED THE SUTURE WAS CAUGHT INSIDE OF THE PATIENT'S BODY AND WAS CUT TO REMOVE THE CATHETER. PART OF THE SUTURE REMAINED INSIDE THE PATIENT'S BODY. IN ADDITION, IT IS UNKNOWN WHAT WAS CONNECTED TO THE DRAIN FITTING. THE FITTING WAS NOT SECURELY ATTACHED AT FIRST INSPECTION. NO FORCE WAS EXERTED ON THE CATHETER. THE PATIENT'S PHYSICAL ACTIVITY LEVEL IS UNKNOWN. ALSO, THE DEVICE PACKAGE WAS STORED VERTICALLY AND NOT DAMAGED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 16872618 ↗
• InjuryApr 12, 2023Material Separation; Material Separation

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

  Patient problems: Foreign Body In Patient

  MAUDE report 16727607 ↗
• MalfunctionMar 17, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE CATHETER IN AN ULTRATHANE MULTIPURPOSE DRAINAGE SET LEAKED. THE DEVICE WAS REQUIRED FOR ABSCESS DRAINAGE AND WAS PLACED IN THE PATIENT BY RIGHT HEPATIC DUCT APPROACH. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE AIR, AIR ENTERED FROM THE CONNECTION BETWEEN THE HUB AND CATHETER. AS A RESULT, A NEW, LIKE DEVICE WAS OBTAINED TO SUCCESSFULLY 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 13802001 ↗
• InjuryJun 10, 2021Fluid/Blood Leak; Leak/Splash; Material Separation; Fluid/Blood Leak; Leak/Splash; Material Separation

  IT WAS REPORTED A PATIENT REQUIRED PLACEMENT OF A DRAINAGE CATHETER FROM AN ULTRATHANE MULTIPURPOSE DRAINAGE SET FOR A BILIARY DRAINAGE PROCEDURE. APPROXIMATELY A WEEK AFTER THE DEVICE WAS PLACED IN THE PATIENT'S BILE DUCT VIA SELDINGER TECHNIQUE WITH "AN APPROACH FROM BODY SURFACE", DRAINAGE (ASPIRATION) WAS UNABLE TO BE COMPLETED AND DAMAGE WAS NOTED FROM THE SUTURE AREA OF THE CATHETER. THE DEVICE WAS CONFIRMED TO HAVE LEAKED. AS THE PHYSICIAN ATTEMPTED TO EXCHANGE THE CATHETER WITH ANOTHER, IT SEPARATED. CONSEQUENTLY, A COMPETITOR DEVICE WAS PLACED. NO OTHER ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11977968 ↗
• MalfunctionDec 16, 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 Consequences Or Impact To Patient

  MAUDE report 11019923 ↗
• MalfunctionJul 16, 2020Material Frayed; Difficult to Advance; Material Frayed; 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 10283768 ↗
• InjuryJul 16, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED SUCCESSFULLY DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY DRAINAGE (PCTD) PROCEDURE IN THE COMMON BILE DUCT. THE PATIENT WAS OBSERVED POST-OP AND APPROXIMATELY THREE HOURS LATER, THE DEVICE WAS FOUND TO BE LEAKING FLUID AT THE HUB. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7691817 ↗
• MalfunctionJun 1, 2018Aspiration Issue; Aspiration Issue

  IT WAS REPORTED A ULTRATHANE MULTIPURPOSE DRAINAGE SET WAS PLACED IN THE INTRAHEPATIC BILE DUCT AND WHEN ASPIRATING BILE BEFORE BEGINNING DRAINAGE, AIR ENTRY WAS OBSERVED. THE DEVICE WAS REMOVED AND REPLACED WITH A LIKE DEVICE 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 7560747 ↗
• MalfunctionNov 15, 2017Sticking; Device Contamination with Chemical or Other Material

  NEPHROSTOMY WAS PERFORMED. THE COMPONENT DRAINAGE CATHETER AND THE STIFFENING CANNULA WERE ADVANCED AS A UNIT TO THE TARGET LESION OVER A WIRE GUIDE. AFTER THE CATHETER REACHED THE DESIRED POSITION, THE PHYSICIAN ATTEMPTED TO PULL THE STIFFENING CANNULA OUT OF THE CATHETER, BUT IT WOULD NOT BE. THE CANNULA SEEMED TO BE STUCK AT THE POINT NEAR THE TIP OF THE CATHETER. THEREFORE, THE CATHETER AND THE STIFFENING CANNULA WERE RETRIEVED OUT OF THE BODY TOGETHER AND ANOTHER DEVICE WAS USED INSTEAD WITHOUT PROBLEMS. IT WAS NOTED THAT AN OPAQUE CRYSTAL SUBSTANCE WAS FOUND ON THE SURFACE OF THE STIFFENING CANNULA

  Patient problems: No Information

  MAUDE report 7034683 ↗
• MalfunctionNov 8, 2017Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS NOTED PRIOR TO THE PROCEDURE THAT THERE WAS THE DAMAGE TO THE STERILE PACKAGING OF THE DEVICE. THIS WAS CONFIRMED UPON PRODUCT ARRIVAL.

  Patient problems: No Patient Involvement

  MAUDE report 7010545 ↗
• MalfunctionSep 8, 2017Leak/Splash; Leak/Splash

  AN INTERNATIONAL CUSTOMER REPORTED THAT WHEN FLUSHING THE ULTRATHANE MULTIPURPOSE DRAINAGE SET DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE, THE PHYSICIAN CONFIRMED FLUID LEAKAGE FROM THE HUB. ANOTHER DEVICE WAS USED FOR THE PROCEDURE INSTEAD.

  Patient problems: No Patient Involvement

  MAUDE report 6851697 ↗
• InjuryAug 1, 2016Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE DEVICE FROM THE PATIENT'S BODY, IT WAS DIFFICULT TO WITHDRAW THE CATHETER DUE TO ADHESION OF SUTURE OF THE CATHETER AND BODY TISSUE. THE PHYSICIAN WAS ABLE TO WITHDRAW THE CATHETER, HOWEVER THE SUTURE GOT SEPARATED AND REMAINED IN THE PATIENT'S BODY. AT A LATER DATE, THE SURGICAL OPERATION WAS CONDUCTED AGAIN AND THE SUTURE WAS REMOVED WITH A SNARE.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 5837335 ↗