Argyle 8811313010Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10884521004085), received between Nov 13, 2017 and Jun 2, 2025 — classified as 1 death, 8 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Migration” (49 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 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Break; Break

  ACCORDING TO THE REPORTER, ON THE SECOND DAY OF PLACEMENT, DURING DIALYSIS AFTER CATHETERIZATION, FLUID LEAKED FROM THE EXTRACORPOREAL EXTENSION. THERE WAS A LEAK AT THE EXIT SITE, WHICH REFERRED TO THE EXTERNAL SEGMENT OF THE CATHETER EXTENDING FROM THE SKIN. A TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS DONE PRIOR TO USE WITH NO ANOMALIES OBSERVED. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE, AND NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. NO LOTIONS OR MEDICATIONS WERE USED TO TREAT THE PATIENT. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE, AND IT WAS TYPICALLY UTILIZED TO CLEAN THE CATHETER IN ITS ENTIRETY. NO OINTMENTS WERE UTILIZED AT THE EXIT SITE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING THE AREA. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE. CLEANING AGENT WAS NEVER SWITCHED OR MIXED OVER THE LIFE OF THE CATHETER, AND SEPSIDERM WAS NOT USED TO CLEAN CATHETERS ON THE SITE. THERE HAD BEEN NO RECENT PROTOCOL CHANGE FOR CLEANING AGENTS USED, AND THE PATIENT THEMSELVES WAS NOT USING ANY TYPE OF CLEANING AGENT OR ANTIBIOTIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127848 ↗
• InjuryMay 19, 2025Break; Break

  ACCORDING TO THE REPORTER, AFTER DIALYSIS, THE PD (PERITONEAL DIALYSIS) CATHETER HAD A CRACK/HOLE/TEAR IN THE TUBE, AND THERE WAS A LEAK LOCATED AT THE CATHETER SHAFT. THE CLEANING AGENTS USED ON THE DEVICE WERE VANCOMYCIN AND CEFTAZIDIME. A TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THE CLINICAL CONSEQUENCE REQUIRED REPAIRING THE DEFECTIVE CATHETER BY CLEANLY CUTTING IT OFF, REPLACING THE CONNECTION SCREW AND TRANSFER SYSTEM, AND PROVIDING PROPHYLACTIC CARE FOR PERITONITIS WITH VANCOMYCIN AND CEFTAZIDIME. THE BROKEN CATHETER TUBE WAS CONNECTED TOGETHER WITH A COMPETITOR'S LUER-LOCK CONNECTION. THE PERSONAL INJURY INVOLVED ABDOMINAL EMPTYING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22044684 ↗
• MalfunctionMar 19, 2025Break; Break

  ACCORDING TO THE REPORTER, AFTER THE PACKAGE WAS OPENED, THE CATHETER WAS INSPECTED, AND THE CATHETER AT THE CUFF WAS FOUND TO BE DAMAGED. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. THERE WAS NO DAMAGE TO THE OUTER AND INNER PACKAGING. AS A REMEDIAL ACTION, THE PRODUCT WAS REPLACED ON THE SAME DAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642707 ↗
• MalfunctionMar 3, 2025Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER WAS INSERTED ON J(B)(6) 2025. THE PATIENT WAS DISCHARGED ON (B)(6) 2025. ON THE DAY OF THE EVENT, THERE WAS A LIQUID LEAK FROM A PART APPROXIMATELY 1 CM FROM THE EXIT SITE, AND A CRACK WAS CONFIRMED. OINTMENT WAS NOT UTILIZED AT THE EXIT SITE. THERE WAS NO PROBLEM WITH THE CONNECTOR. THE WOUND DRESSING(S) DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. ETHANOL WAS THE CLEANING AGENT TO DISINFECT THE EXIT SITE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21501943 ↗
• InjuryDec 27, 2024Break; Break

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, WHEN THE NURSE WAS PERFORMING THE PERITONEAL DIALYSIS HEPARIN SALINE FLUSHING FOR THE PATIENT, IT WAS FOUND THAT THE CATHETER RUPTURED AND LEAKED WATER AT ABOUT 3CM OF THE FRONT SECTION AT THE CONNECTION BETWEEN THE PERITONEAL DIALYSIS CATHETER AND THE PEPTIDE CONNECTOR. THE DIALYSIS CATHETER WAS IMMEDIATELY CLAMPED AND WAS REPORTED TO THE DOCTOR, THEN REPLACED THE TITANIUM CONNECTOR AND USED IT NORMALLY. THE PATIENT HAD AN INFECTION DUE TO THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21028316 ↗
• MalfunctionNov 11, 2024Migration; Migration

  ACCORDING TO THE REPORTER, AFTER SUCCESSFUL IMPLANTATION, THE PERITONEAL DIALYSIS CATHETER DRIFTED. THE CATHETER HAS BEEN IN PLACE FOR ONE TO THREE MONTHS. THERE WAS NO LEAK. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE REMEDIAL ACTION WAS DEFECATE AND EXERCISE. THE REPORTED PRODUCT WAS NOT REPLACED. THE TREATMENT WAS CONTINUED AND COMPLETED. THERE WAS NORMAL BLOOD LOSS DURING SURGERY. A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652637 ↗
• MalfunctionNov 11, 2024Migration; Migration

  ACCORDING TO THE REPORTER, AFTER SUCCESSFUL IMPLANTATION, THE PERITONEAL DIALYSIS CATHETER DRIFTED. THE CATHETER HAS BEEN IN PLACE FOR ONE TO THREE MONTHS. THERE WAS NO LEAK. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE REMEDIAL ACTION WAS DEFECATE AND EXERCISE. THE REPORTED PRODUCT WAS NOT REPLACED. THE TREATMENT WAS CONTINUED AND COMPLETED. THERE WAS NORMAL BLOOD LOSS DURING SURGERY. A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652448 ↗
• MalfunctionNov 11, 2024Migration; Migration

  ACCORDING TO THE REPORTER, AFTER SUCCESSFUL IMPLANTATION, THE PERITONEAL DIALYSIS CATHETER DRIFTED. THE CATHETER HAS BEEN IN PLACE FOR ONE TO THREE MONTHS. THERE WAS NO LEAK. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE REMEDIAL ACTION WAS DEFECATE AND EXERCISE. THE REPORTED PRODUCT WAS NOT REPLACED. THE TREATMENT WAS CONTINUED AND COMPLETED. THERE WAS NORMAL BLOOD LOSS DURING SURGERY. A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652446 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, AFTER SUCCESSFUL IMPLANTATION, THE PERITONEAL DIALYSIS CATHETER DRIFTED. THE CATHETER HAD BEEN IN PLACE FOR ONE TO THREE MONTHS. THERE WAS NO LEAK. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE REMEDIAL ACTION WAS DEFECATE AND EXERCISE. THE REPORTED PRODUCT WAS NOT REPLACED. THE TREATMENT WAS CONTINUED AND COMPLETED. THERE WAS NORMAL BLOOD LOSS DURING SURGERY. A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20574242 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, AFTER SUCCESSFUL IMPLANTATION, THE WHOLE TUBE OF THE IMPLANTED PART OF THE PERITONEAL DIALYSIS CATHETER DRIFTED. IT WAS STATED THAT X-RAYS WERE TAKEN AFTER THE CATHETER WAS INSERTED TO MAKE SURE THAT IT WAS IN PLACE. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. FLUSHING/PRIMING WAS NOT DONE PRIOR TO USE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. TEGO WAS NOT UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE WOUND WAS SUTURED WITHOUT DRESSING. THE WOUND DRESSING DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING THE AREA. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE. THERE WAS NO OINTMENT APPLIED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO REMEDIAL ACTION DONE TO ADDRESS THE ISSUE. THE SURGERY WAS COMPLETED. THERE WAS NO BLOOD LOSS. A BLOOD TRANSFUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571785 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE PERITONEAL CATHETER DRIFTED AFTER SUCCESSFUL IMPLANTATION. THE CATHETER HAD BEEN IN PLACE FOR ONE TO THREE MONTHS. THERE WERE NO ABNORMALITIES OBSERVED ON THE EQUIPMENT PRIOR TO USE. THE FLUSHING WAS NOT PERFORMED PRIOR TO USE. THERE WERE NO OTHER DEFECTS OR DAMAGES TO THE PRODUCT. THERE WERE NO OTHER PRODUCTS USED WITH THE EQUIPMENT. THE CATHETER WAS NOT REPAIRED. THERE WAS NO TYPE OF CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LEAK. THERE WAS A NORMAL INTRAOPERATIVE BLOOD LOSS. THERE WAS NO BLOOD TRANSFUSION REQUIRED DUE TO THE EVENT. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REMEDIAL ACTION TAKEN, AND THE REPORTED PRODUCT WAS NOT REPLACED, AND THE TREATMENT WAS COMPLETE. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571223 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE ENTIRE PERITONEAL CATHETER DRIFTED (BALLOONED) AFTER SUCCESSFUL IMPLANTATION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THERE WAS NO ISSUE WITH THE LUER ADAPTER. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO REMEDIAL ACTION TAKEN TO ADDRESS THE ISSUE. THE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT WAS COMPLETED. NORMAL BLOOD LOSS DURING SURGERY AND BLOOD TRANSFUSION WERE NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570969 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE ENTIRE PERITONEAL CATHETER DRIFTED (BALLOONED) AFTER SUCCESSFUL IMPLANTATION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THERE WAS NO ISSUE WITH THE LUER ADAPTER. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CATHETER THAT CAME WITH THE KIT WAS NOT THE ONE USED. THERE WAS NO REMEDIAL ACTION TAKEN TO ADDRESS THE ISSUE. THE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT WAS COMPLETED. NORMAL BLOOD LOSS DURING SURGERY AND BLOOD TRANSFUSION WERE NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570955 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE ENTIRE PERITONEAL CATHETER DRIFTED (BALLOONED) AFTER SUCCESSFUL IMPLANTATION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CATHETER THAT CAME WITH THE KIT WAS NOT THE ONE USED. THERE WAS NO REMEDIAL ACTION TAKEN TO ADDRESS THE ISSUE. THE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT WAS COMPLETED. NORMAL BLOOD LOSS DURING SURGERY AND BLOOD TRANSFUSION WERE NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570947 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE ENTIRE PERITONEAL CATHETER DRIFTED (BALLOONED) AFTER SUCCESSFUL IMPLANTATION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WAS NO LEAK AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE CATHETER THAT CAME WITH THE KIT WAS NOT THE ONE USED. THERE WAS NO REMEDIAL ACTION DONE TO ADDRESS THE ISSUE. THE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570935 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE ENTIRE PERITONEAL CATHETER DRIFTED (BALLOONED) AFTER SUCCESSFUL IMPLANTATION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WAS NO LEAK AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS NOT DONE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO REMEDIAL ACTION WAS DONE TO ADDRESS THE ISSUE. THE REPORTED PRODUCT WAS NOT REPLACED. THE TREATMENT WAS COMPLETED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NORMAL BLOOD LOSS DURING SURGERY AND NO BLOOD TRANSFUSION REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570917 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE ENTIRE PERITONEAL CATHETER DRIFTED (BALLOONED) AFTER SUCCESSFUL IMPLANTATION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WAS NO LEAK AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS NOT DONE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THERE WAS NO CLEANING AGENT WAS USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO REMEDIAL ACTION WAS DONE TO ADDRESS THE ISSUE. THE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT PROCEEDED AND COMPLETED. NORMAL BLOOD LOSS DURING SURGERY AND BLOOD TRANSFUSION WAS NOT REQUIRE DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570907 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE ENTIRE PERITONEAL CATHETER DRIFTED (BALLOONED) AFTER SUCCESSFUL IMPLANTATION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WAS NO LEAK AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS NOT DONE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE CATHETER THAT CAME WITH THE KIT WAS NOT THE ONE USED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO REMEDIAL ACTION DONE TO ADDRESS THE ISSUE. THE TREATMENT WAS COMPLETED. THE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. NORMAL BLOOD LOSS DURING SURGERY AND NO BLOOD TRANSFUSION REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570891 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE ENTIRE PERITONEAL CATHETER DRIFTED (BALLOONED) AFTER SUCCESSFUL IMPLANTATION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WAS NO LEAK AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THERE WAS NO CLEANING AGENT(S) WAS USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO REMEDIAL ACTION WAS DONE TO ADDRESS THE ISSUE. THE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT WAS COMPLETED. NORMAL BLOOD LOSS DURING SURGERY AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570816 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE ENTIRE PERITONEAL CATHETER DRIFTED (BALLOONED) AFTER SUCCESSFUL IMPLANTATION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO LEAK AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. FLUSHING WAS NOT DONE PRIOR TO USE. THE CLEANING AGENT WAS NOT USED ON THE DEVICE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THE CATHETER THAT CAME WITH THE KIT WAS NOT THE ONE USED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO REMEDIAL ACTION DONE TO ADDRESS THE ISSUE. THE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT WAS COMPLETED. NORMAL BLOOD LOSS DURING SURGERY AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570743 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE ENTIRE PERITONEAL CATHETER DRIFTED (BALLOONED) AFTER SUCCESSFUL IMPLANTATION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WAS NO LEAK AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE CATHETER THAT CAME WITH THE KIT WAS NOT THE ONE USED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO REMEDIAL ACTION DONE TO ADDRESS THE ISSUE. THE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT WAS COMPLETED. NORMAL BLOOD LOSS DURING SURGERY AND NO BLOOD TRANSFUSION WAS REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570711 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE ENTIRE PERITONEAL CATHETER DRIFTED (BALLOONED) AFTER SUCCESSFUL IMPLANTATION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO LEAK AND TEGO WAS NOT UTILIZED. THERE WAS LUER ADAPTER ISSUE. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WAS NO CLEANING AGENT(S) WAS USED ON THE DEVICE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO REMEDIAL ACTION WAS DONE TO ADDRESS THE ISSUE. THE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT WAS COMPLETED. NORMAL BLOOD LOSS DURING SURGERY AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570679 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE ENTIRE PERITONEAL CATHETER DRIFTED (BALLOONED) AFTER SUCCESSFUL IMPLANTATION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WAS NO LEAK AND TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE CATHETER THAT CAME WITH THE KIT WAS NOT THE ONE USED. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO REMEDIAL ACTION WAS DONE TO ADDRESS THE ISSUE. THERE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT WAS COMPLETED. NORMAL BLOOD LOSS DURING SURGERY AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570620 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, THE WHOLE PERITONEAL CATHETER DRIFTED (BALLOONED) AFTER SUCCESSFUL IMPLANTATION. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LEAK, AND TEGO WAS NOT UTILIZED. THERE WAS NO ISSUE WITH THE LUER ADAPTER. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WAS NO EXCESSIVE FORCE USE ON THE DEVICE. THERE WAS NO REMEDIAL ACTION TAKEN TO ADDRESS THE ISSUE. THE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568824 ↗
• MalfunctionOct 30, 2024Migration; Migration

  ACCORDING TO THE REPORTER, AFTER SUCCESSFUL PERITONEAL DIALYSIS CATHETER IMPLANTATION, THE WHOLE TUBE OF THE IMPLANTED PART OF THE PERITONEAL CATHETER DRIFTED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS NOT DONE PRIOR TO USE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THE CATHETER WAS NOT REPAIRED. IT WAS ALSO STATED THAT THE ENTIRE CATHETER OF THE IMPLANT BALLOONED. THERE WAS NO LEAK, AND THE TEGO WAS NOT UTILIZED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EVENT. THERE WAS NO REMEDIAL ACTION WAS DONE TO ADDRESS THE ISSUE. THE CATHETER KIT THAT CAME WITH THE CATHETER WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568810 ↗