Argyle 8817278006Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521004252), received between Apr 23, 2018 and Nov 28, 2022 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DOCTOR USED THE FALLER TUNNELLER AND IT WAS PULLING THE CUFF THROUGH THE SOFT TISSUES. THE DOCTOR HAD TO DO EXTENSIVE MANIPULATION AND THE CUFF DISLODGED FROM THE CATHETER ITSELF EVENTUALLY. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. NO CLEANING AGENT USED ON THE DEVICE. CHLORHEXIDINE WAS THE CLEANING AGENT USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS DONE PRIOR TO USE WITH NORMAL RESULTS. TUNNELLER STYLET WAS THE PRODUCT BEING UTILIZED WITH DEVICE. NO ADDITIONAL ACTION REQUIRED AS THE CATHETER WAS SAFELY IMPLANTED AND IN USE. IT WAS SAID THAT THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WERE NOT REQUIRED. NO INTERVENTION/TREATMENT REQUIRED AS A RESULT. THERE WERE NO OTHER PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15873840 ↗
• MalfunctionNov 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DOCTOR USED THE FALLER TUNNELLER AND IT WAS PULLING THE CUFF THROUGH THE SOFT TISSUES. THE DOCTOR HAD TO DO EXTENSIVE MANIPULATION AND THE CUFF DISLODGED FROM THE CATHETER ITSELF EVENTUALLY. IT WAS SAID THAT THE DOCTOR WAS SUCCESSFUL IN PLACING THE CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 15869071 ↗
• MalfunctionNov 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DOCTOR USED THE FALLER TUNNELLER AND IT WAS PULLING THE CUFF THROUGH THE SOFT TISSUES. THE DOCTOR HAD TO DO EXTENSIVE MANIPULATION AND THE CUFF DISLODGED FROM THE CATHETER ITSELF EVENTUALLY. IT WAS SAID THAT THE DOCTOR WAS SUCCESSFUL IN PLACING THE CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 15869024 ↗
• MalfunctionNov 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DOCTOR USED THE FALLER TUNNELLER AND IT WAS PULLING THE CUFF THROUGH THE SOFT TISSUES. THE DOCTOR HAD TO DO EXTENSIVE MANIPULATION AND THE CUFF DISLODGED FROM THE CATHETER ITSELF EVENTUALLY. IT WAS SAID THAT THE DOCTOR WAS SUCCESSFUL IN PLACING THE CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 15869007 ↗
• MalfunctionSep 13, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING USE, A LEAK WAS NOTED AT THE FIRST CUFF FROM OUTER CAVITY OF ABDOMEN (EXIT SITE) WHICH RESULTED INTO SOLUTION COLLECTION (NOT IN THE PERITONEAL CAVITY BUT BEFORE THAT) AND LEAKAGE FROM THE CAVITY. THE CATHETER WAS NOT REPAIRED. TEGO WAS NOT UTILIZED AND NO LUER ADAPTER ISSUE. BETADINE WAS THE CLEANING AGENT USED ON THE DEVICE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459799 ↗
• InjuryJan 8, 2021Break; Break

  ACCORDING TO THE REPORTER, THE CAP FOR THE TUNNELING STYLET OF THE PERITONEAL DIALYSIS CATHETER FELL OFF INTO THE PATIENT DURING SURGERY. IT WAS ALSO STATED THAT IT WAS NOT DISCOVERED FOR FEW DAYS AND THEY HAD TO GO BACK INTO THE PATIENT TO GET IT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure; Unspecified Infection

  MAUDE report 11138617 ↗
• MalfunctionDec 21, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, HOLE AND LEAK WERE OBSERVED NEAR AT THE CUFF OF THE DEVICE. THE DEVICE WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS ALSO STATED THAT THE PROCEDURE WAS COMPLETED, BLOOD TRANSFUSION WAS NOT REQUIRED, THE DEVICE WAS REPLACED AS THE INTERVENTION/TREATMENT FOR THE LEAKAGE, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS NOT PERFORMED (ONLY CUFF WAS WET WITH SALINE AND HEPARIN), THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE AND THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT. THERE WAS NO DAMAGE TO THE DEVICE'S EXTERNAL PACKAGING AND BOX. THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA AND IT DID NOT EXCEED TO 30 MINUTES. BETADINE WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS A BLOOD LOSS OF 2-3 ML (MILLILITER) AND NORMAL SALINE WAS USED AS THE CLEANING AGENT ON THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11048170 ↗
• MalfunctionAug 12, 2020Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER WAS NOTED TO BE LEAKING. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 10395891 ↗
• MalfunctionDec 10, 2019Break; Break

  ACCORDING TO THE REPORTER, THERE WAS FOUND TO BE CATHETER LEAKAGE DURING SERVICING OF THE DEVICE. IT WAS NOTED THAT THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 9446677 ↗
• MalfunctionMay 7, 2018Material Discolored; Material Deformation; Material Discolored; Material Deformation

  ACCORDING TO THE REPORTER, THE CATHETER IS BREAKING DOWN AT THE EXIT SITE AND TURNING OPAQUE. THE CATHETER WAS INSERTED IN 2012, AND IN (B)(6) 2015, THEY NOTICED THE OPAQUENESS AND RECENTLY THEY STARTED NOTICING THE BUBBLING. IT WAS STATED THAT THE CATHETER IS STILL IN USE, AND THEY EXPECT THAT IT WILL NEED TO BE REMOVED SHORTLY BUT THIS WILL BE A MEDICAL DECISION. IT WAS REPORTED THAT THE STANDARD MAINTENANCE PROCEDURES INCLUDE THE PATIENT SHOWERS ARE ALLOWED, SO DRESSINGS CAN BE CHANGED ON AVERAGE FROM DAILY TO EVERY OTHER DAY. THERE IS NO DIRECTION PROVIDED TO PATIENTS REGARDING THE TYPE OF BODY CLEANER OR SHAMPOO/CONDITIONER AND TO USE GENTLE ANTIBACTERIAL SOAP (LOOKING INTO POSSIBLE OPTIONS FOR NON-ANTIBACTERIAL). PATIENTS CAN ALSO CLEAN THE EXIT SITE WITH VITAMIN C FLUSH FOLLOWING THE SHOWER WITH SALINE-BASED SOLUTION. OTHER OPTIONS INCLUDE APPLYING ON 3 ANTIBIOTIC CREAMS. A DRESSING SHOULD BE APPLIED ONCE SKIN IS DRY AND A 2X2 GAUZE DRESSING MAY BE USED OVER THE TOP OF CREAM, THEN THE DRESSING IS APPLIED. THERE IS NO SKIN PREPARATION OR ALCOHOL USE TO PREPARE SKIN FOR DRESSING ADHESIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7490202 ↗
• MalfunctionApr 23, 2018Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, AFTER THE INTRODUCER NEEDLE WAS INTRODUCED INTO THE PATIENT'S CAVITY, THE GUIDE WIRE WAS INSERTED INTO THE INTRODUCER NEEDLE AND WAS STUCK AFTER 9CM WAS REACHED. THE GUIDE WIRE COULD NOT BE ADVANCED OR WITHDRAWN FROM THE INTRODUCER NEEDLE. THE GUIDE WIRE AND INTRODUCER NEEDLE WAS REMOVED TOGETHER AS A WHOLE, AND A NEW KIT WAS OPENED TO CONTINUE THE PROCEDURE. THE CUSTOMER REPORTED THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7450893 ↗