Argyle 8817278007Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521004269), received between May 15, 2018 and Mar 18, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SPECIALIST ON DUTY WAS INSERTING THE PERITONEAL CATHETER ACCORDING TO INSTITUTIONAL PROTOCOL, BUT THE GUIDEWIRE DID NOT PASS THROUGH THE NEEDLE AND RESISTANCE WAS GENERATED. THE GUIDE WIRE WAS STILL IN THE INTRODUCER NEEDLE (BASED ON THE VIDEO). THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE, AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. IT WAS NECESSARY TO OPEN A NEW CATHETER, WHICH WAS INSERTED AND WORKED WITHOUT COMPLICATIONS. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924275 ↗
• MalfunctionMay 5, 2022Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT PERITONEAL CATHETER IMPLANTATION THAT SUBSEQUENTLY PRESENTED A LEAK AND CATHETER RUPTURE WAS IDENTIFIED. THE OPERATOR OF THE PRODUCT THAT WAS INVOLVED WAS A HEALTH PROFESSIONAL. THE CATHETER WAS NOT REPAIRED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION AND THE EVENT DID NOT LOAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287731 ↗
• MalfunctionDec 10, 2021Product Quality Problem; Obstruction of Flow; Product Quality Problem; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE PATIENT WAS REFERRED TO A PERITONEAL CATHETER IMPLANTATION PROCEDURE. DURING THE PROCEDURE, THE HEALTHCARE PERSONNEL SHOWED DIFFICULTY IN PASSING THE CATHETER THROUGH THE PULL APART DILATOR SHEATH. MULTIPLE ATTEMPTS WERE MADE AT LUBRICATING THE DEVICE, HOWEVER, THEY WERE UNSUCCESSFUL. IT WAS MENTIONED THAT THE CATHETER'S PERMEABILITY WAS LUBRICATED WITH SODIUM CHLORIDE 0.9% AND HAD OCCLUSION AS IT DID NOT PASS THROUGH THE SHEATH AND DID NOT ALLOW PERMEABILITY. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THERE WERE NO ABNORMALITIES OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION AND THE PULL APART DILATOR SHEATH THAT WAS USED WAS THE ONE INCLUDED THE KIT. THERE WERE NO OTHER DEFICIENT PRODUCTS USED DURING THE EVENT. THE MEDICAL DEVICE WAS CHANGED FOR ANOTHER OF THE SAME REFERENCE ON THE SAME DAY OF THE EVENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12976987 ↗
• InjuryDec 10, 2021Break; Break

  ACCORDING TO THE REPORTER, THE PATIENT ARRIVED AT THE RENAL UNIT CONSCIOUS, ORIENTED, AND REFERRED TO THE LEAK OF PERITONEAL FLUID T HROUGH CATHETER. A PHYSICAL EXAMINATION WAS PERFORMED, AND PERITONEAL FLUID LEAKAGE WAS EVIDENCED AT THE EXIT ORIFICE LEVEL/OUTLET HOLE (EVIDENCED WITH VIDEO). PERITONEAL FLUID WAS DRAINED AND THE TRANSPARENT FLUID WAS VISUALIZED, WITHOUT FIBRIN, ADEQUATE DIALYSIS MECHANICS. THE NEPHROLOGIST WAS ALSOX INFORMED WHO INDICATED ANTIBIOTIC PROPHYLAXIS CEFAZOLINE 1 GR IV AND AMIKACIN 100 MG IV WAS APPLIED AS A FIRST URGENT DOSE IN THE RENAL UNIT, WHICH WAS WELL TOLERATED, AND THEN APPLIED TWO DOSES FOR 48 HOURS, SUSPEND DIALYSIS, THEN ORDERED REMOVAL AND PLACEMENT OF AN URGENT PERITONEAL CATHETER (ORDERED DUE TO ITS DYSFUNCTION AND GROWTH OF PSEUDOMONAS IN PERITONEAL FLUID), PATIENT WEIGHT WAS 92 KG, AND BLOOD PRESSURE WAS 130/80 MMHG. MANAGEMENT OF URGENT SURGERY SCHEDULING WAS CARRIED OUT WITH THE NURSING COORDINATION OF THE BUENOS AIRES CLINIC SURGERY SERVICE WHO ASSIGNED A CONSULTATION WITH ANESTHESIOLOGY FOR (B)(6), 2021, PENDING TO ASSIGN SURGERY SCHEDULE, PRE-LABORATORY TAKING WAS CARRIED OUT. SURGICAL, HEMOGLOBIN (HG), PROTHROMBIN TIME (PT), PARTIAL

  Patient problems: Bacterial Infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975633 ↗
• InjuryDec 10, 2021Break; Break

  ACCORDING TO THE REPORTER, THE NURSE STATED THAT THE PATIENT WENT TO THE RENAL UNIT, CONSCIOUS, ORIENTED, AND WHEN THE PRODUCT WAS BEING USED AT THE HOSPITAL, THERE WAS LEAKAGE OF PERITONEAL FLUID BY CATHETER. PHYSICAL EXAMINATION WAS PERFORMED AND PERITONEAL FLUID LEAKAGE WAS EVIDENCED AT THE LEVEL OF THE CATHETER AND TITANIUM ADAPTER JUNCTION, URGENT TITANIUM LINE AND ADAPTER CHANGE WAS PERFORMED, THEN PERMANENT PERITONEAL FLUID WITH DIANEAL X 2.5% X 2000 ML FOR A PERIOD OF THREE HOURS AND SUBSEQUENTLY DRAINED TURBID LIQUID, ON THE ORDER OF THE NEPHROLOGIST, FLUID CULTURE, GRAM, ANTIBIOGRAM, CELL COUNT, STARTED AMIKACIN 100 MG IP (INTRAPERITONEAL INJECTION) EVERY 24 HOURS AND CEFAZOLINE 1 GR EVERY 24 HOURS IP PERFORMED. THE OUTCOME WAS THAT THE PATIENT PRESENTED A KLEBSIELLA PNEUMONIAE PERITONITIS RECIO, COMPLETE SCHEME OF ANTIBIOTIC CEFEPIME PERFORMED AND PERITONITIS RESOLVED. NO HOSPITALIZATION REQUIRED. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK FROM THE LUER ADAPTER, NO CRACK OBSERVED IN THE LUER ADAPTER, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE.

  Patient problems: Peritonitis

  MAUDE report 12975609 ↗
• MalfunctionNov 26, 2019Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING DIALYSIS, WHEN THEY WENT TO THE TUNNEL UNDER THE SKIN, CATHETER WAS ATTACHED TO THE WHITE END, WHEN THEY PULLED IT THROUGH, THE CATHETER AND THE WHITE END HAD FALLEN OFF, METAL TUNNELER STILL ATTACHED TO THE CATHETER, IT WAS MENTIONED THAT THEY WERE ABLE TO RETRIEVE THE CATHETER. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION DONE, NOTHING UNUSUAL OBSERVED PRIOR TO USE, USED ANEW CATHETER TO RESOLVE AND COMPLETE THE TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9373968 ↗
• MalfunctionMay 15, 2018Occlusion Within Device; Occlusion Within Device

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DILATOR COULD NOT PASS INTO THE PERITONEAL CATHETER. THERE WAS NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7514625 ↗