Cook G09503Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00827002095038), received between Nov 17, 2016 and Sep 26, 2024 — classified as 18 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED DURING A NEPHROSTOMY PROCEDURE ON A PATIENT OF UNKNOWN AGE AND GENDER. THE DEVICE WAS TO BE USED FOR URINE DRAINAGE OUT OF THE KIDNEYS. THE LEAKAGE OF BLOOD WAS NOTICED AT THE MAC-LOC LEVER AREA OF THE PLASTIC HUB FROM TWO DEVICES OF THE SAME LOT DURING THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER SAME LIKE-DEVICE FROM A DIFFERENT LOT. IT WAS NOTED THAT THE FITTING WAS SECURELY ATTACHED AT FIRST INSPECTION. 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 20315797 ↗
• MalfunctionJun 20, 2024Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  ADDITIONAL INFORMATION WAS PROVIDED 27JUN2024. THE ISSUE WAS NOTED AT THE CONCLUSION OF THE PROCEDURE. THE PATIENT HAD NOT BEEN REMOVED FROM THE PROCEDURE TABLE. THE PATIENT WAS RE-PREPPED AND DRAPED, AND THE TUBE WAS EXCHANGED FOR A NEW ONE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19576808 ↗
• MalfunctionMay 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER BROKE APART. DURING A PROCEDURE ON (B)(6) 2022, THE CATHETER BROKE APART "AT THE STOPCOCK" AFTER INSERTION. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14492750 ↗
• InjuryDec 17, 2021Fluid/Blood Leak; Fluid/Blood Leak

  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 13029027 ↗
• InjuryMar 3, 2020Material Separation; Material Separation

  IT WAS REPORTED A (B)(6) YEAR OLD MALE REQUIRED PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR A LIVER ABSCESS DRAIN EXCHANGE PROCEDURE. THE DRAIN WAS PLACED ON (B)(6) 2020. ON (B)(6) 2020, THE DRAIN WAS UNLOCKED, CUT, AND SLOWLY RETRACTED WITH NO RESISTANCE. AFTER REMOVAL, THE OPERATOR NOTED THAT THE DISTAL TIP OF THE CATHETER APPEARED TO REMAIN IN THE PATIENT. A CT SCAN WAS PERFORMED, SHOWING AN APPROXIMATELY 1 CM PIECE OF THE DISTAL TIP OF THE CATHETER RETAINED IN THE "CENTRAL PORTION OF THE OLD LIVER ABSCESS CAVITY." NO OTHER ADVERSE EVENTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9781006 ↗
• MalfunctionFeb 28, 2020Leak/Splash; Leak/Splash

  THE DEVICE WAS RETURNED 06MAR2020 AND EXAMINATION OF THE RETURNED PRODUCT SHOWED THE CATHETER IN TWO SECTIONS AND A CRACK IN THE LUER PORTION OF THE MAC-LOC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9769244 ↗
• InjuryNov 13, 2019Material Separation; Material Separation

  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 9316067 ↗
• InjuryOct 15, 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 Code Available

  MAUDE report 9193110 ↗
• MalfunctionSep 26, 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 9125176 ↗
• InjuryJul 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  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 8830816 ↗
• InjuryJul 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  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 8830815 ↗
• InjuryApr 2, 2019Material Separation; Material Separation

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

  Patient problems: No Code Available

  MAUDE report 8472736 ↗
• MalfunctionNov 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED IN ADDITIONAL INFORMATION RECEIVED ON 05DEC2018 THAT THE HUB DETACHED FROM THE CATHETER AS THE TECH WAS TAKING THE DEVICE OUT OF THE PACKAGE. THE SUTURE STRING DETACHED AT THAT TIME AS WELL. IT APPEARED THAT NOTHING WAS WRONG WHEN THE DEVICE WAS INSIDE OF THE PACKAGE. IT WAS LATER CLARIFIED ON (B)(6) 2018 THAT THE ISSUE WAS WITH THE HUB COMING OFF OF THE CATHETER, NOT THE SUTURE STRING BEING DETACHED OR BROKEN. WHEN THE HUB CAME OFF OF THE CATHETER, THE SUTURE STRING WAS NO LONGER ATTACHED TO THE CATHETER EITHER.

  Patient problems: No Patient Involvement

  MAUDE report 8070357 ↗
• MalfunctionMay 10, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED A ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED FOR AN ABSCESS DRAIN WHEN LEAKING AFTER WAS NOTICED AROUND THE HUB. THE DEVICE WAS REMOVED AFTER ABOUT FIVE MINUTES AND A LIKE DEVICE WAS 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 7502931 ↗
• MalfunctionApr 13, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS LEAKING AT THE HUB WHICH REQUIRED THE PATIENT TO HAVE A DRAIN REPLACEMENT. TO DATE, ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT HAVE NOT BEEN MADE AVAILABLE. NO OTHER PATIENT HAM WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 7429597 ↗
• InjuryApr 6, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED FIVE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS FELL OUT ON FIVE DIFFERENT PATIENTS¿ IN PRIOR TWO WEEKS. AS REPORTED, ALL FIVE DEVICES WERE FROM THE SAME LOT AND THREE OF THE FIVE WERE INSERTED BY SENIOR CONSULTANTS. TO DATE, ADDITIONAL INFORMATION REGARDING EVENT DATES, PATIENT DEMOGRAPHICS AND PATIENTS¿ HAS BEEN REQUESTED BUT THE STATUS IS UNKNOWN. THE FOLLOWING MEDWATCH REPORTS ARE ASSOCIATED: 1820334-2018-00863, 1820334-2018-01010, 1820334-2018-01011, AND 1820334-2018-01012.

  Patient problems: No Code Available

  MAUDE report 7405273 ↗
• InjuryApr 6, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED FIVE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS FELL OUT ON FIVE DIFFERENT PATIENTS¿ IN PRIOR TWO WEEKS. AS REPORTED, ALL FIVE DEVICES WERE FROM THE SAME LOT AND THREE OF THE FIVE WERE INSERTED BY SENIOR CONSULTANTS. TO DATE, ADDITIONAL INFORMATION REGARDING EVENT DATES, PATIENT DEMOGRAPHICS AND PATIENTS¿ HAS BEEN REQUESTED BUT THE STATUS IS UNKNOWN. THE FOLLOWING MEDWATCH REPORTS ARE ASSOCIATED: 1820334-2018-00863, 1820334-2018-01010, 1820334-2018-01011, AND 1820334-2018-01013.

  Patient problems: No Code Available

  MAUDE report 7405265 ↗
• InjuryApr 6, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED FIVE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS FELL OUT ON FIVE DIFFERENT PATIENTS¿ IN PRIOR TWO WEEKS. AS REPORTED, ALL FIVE DEVICES WERE FROM THE SAME LOT AND THREE OF THE FIVE WERE INSERTED BY SENIOR CONSULTANTS. TO DATE, ADDITIONAL INFORMATION REGARDING EVENT DATES, PATIENT DEMOGRAPHICS AND PATIENTS¿ HAS BEEN REQUESTED BUT THE STATUS IS UNKNOWN. THE FOLLOWING MEDWATCH REPORTS ARE ASSOCIATED: 1820334-2018-00863, 1820334-2018-01010, 1820334-2018-01011, 1820334-2018-01012, AND 1820334-2018-01013.

  Patient problems: No Code Available

  MAUDE report 7405248 ↗
• InjuryApr 6, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED FIVE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS FELL OUT ON FIVE DIFFERENT PATIENTS¿ IN PRIOR TWO WEEKS. AS REPORTED, ALL FIVE DEVICES WERE FROM THE SAME LOT AND THREE OF THE FIVE WERE INSERTED BY SENIOR CONSULTANTS. TO DATE, ADDITIONAL INFORMATION REGARDING EVENT DATES, PATIENT DEMOGRAPHICS AND PATIENTS¿ HAS BEEN REQUESTED BUT THE STATUS IS UNKNOWN. THE FOLLOWING MEDWATCH REPORTS ARE ASSOCIATED: 1820334-2018-00863, 1820334-2018-01010, 1820334-2018-01011, 1820334-2018-01012, AND 1820334-2018-01013.

  Patient problems: No Code Available

  MAUDE report 7405241 ↗
• InjuryApr 6, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED FIVE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS FELL OUT ON FIVE DIFFERENT PATIENTS¿ IN PRIOR TWO WEEKS. AS REPORTED, ALL FIVE DEVICES WERE FROM THE SAME LOT AND THREE OF THE FIVE WERE INSERTED BY SENIOR CONSULTANTS. TO DATE, ADDITIONAL INFORMATION REGARDING EVENT DATES, PATIENT DEMOGRAPHICS AND PATIENTS¿ HAS BEEN REQUESTED BUT THE STATUS IS UNKNOWN. THE FOLLOWING MEDWATCH REPORTS ARE ASSOCIATED: 1820334-2018-00863, 1820334-2018-01010, 1820334-2018-01011, 1820334-2018-01012, AND 1820334-2018-01013.

  Patient problems: No Code Available

  MAUDE report 7405228 ↗
• MalfunctionApr 4, 2018Material Separation; Material Separation

  IT WAS REPORTED DURING A PELVIC ABSCESS DRAINAGE AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS NOT ATTACHED PROPERLY, WHICH CAUSED AIR TO PASS THROUGH. THIS LEAK WAS FOUND DURING SCHEDULED POSTOPERATIVE CARE DUE TO THE DEVICE NOT HAVING SUCTION. AN ALTERNATIVE DRAIN WAS USED TO CONTINUE DRAINAGE AS INTENDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7398136 ↗
• MalfunctionApr 4, 2018Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT, AFTER THE ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED IN THE PATIENT TO DRAIN AN ABDOMINAL ABSCESS, A LEAK WAS DISCOVERED IN BETWEEN THE HUB AND THE CATHETER SECTIONS OF THE DEVICE. HOWEVER, THE CUSTOMER CONFIRMED THAT NO SEPARATION OF THE HUB OCCURRED. THE COMPLAINT DEVICE WAS REMOVED, AND A NEW PRODUCT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT ADVERSE EVENTS WERE REPORTED. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7396527 ↗
• MalfunctionAug 17, 2017Break; Detachment Of Device Component

  THE LAB MANAGER CONTACTED THE MANUFACTURER DISTRICT MANAGER AND STATED HE JUST RETURNED FROM VACATION AND FOUND THE COMPLAINT DEVICE ON HIS TABLE. HE DID NOT HAVE ANY EVENT DESCRIPTION. FURTHER INFORMATION WAS REQUESTED, BUT NONE WAS RECEIVED. THE RETURNED DEVICE HAD BEEN USED AND WAS FOUND TO HAVE A BREAK IN THE TUBING, AND ITS HUB WAS SEPARATED FROM THE CATHETER. IT IS UNKNOWN IF THIS EVENT OCCURRED DURING A PROCEDURE, OR IF IT RESULTED IN ANY INJURIES OR ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6802015 ↗
• InjuryAug 17, 2017Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE HUB OF THE CATHETER DETACHED, REQUIRING THE DEVICE TO BE REPLACED. ASIDE FROM THE ADDITIONAL PROCEDURE, THERE WERE NO FURTHER INJURIES TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 6799871 ↗
• InjuryAug 15, 2017Detachment Of Device Component

  THE COMPLAINANT REPORTED THAT THE PATIENT HAD A NEPHROSTOMY DRAIN PLACED AND THE HUB CAME OFF OF THE DEVICE 55 DAYS LATER. THE PATIENT REQUIRED ANOTHER PROCEDURE TO REPLACE THE DRAINAGE CATHETER. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 6795094 ↗