Argyle 8888422170Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521055650), received between Apr 13, 2020 and Oct 13, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING VISUAL INSPECTION, THE EXTERNAL CUFF OF THE CATHETER WAS RUPTURED (TEAR / CRACK). IT WAS ALSO STATED THAT THE CATHETER DID NOT PRESENT ANY LEAK. HOWEVER, IT WAS CHANGED WITH ANOTHER CATHETER. THERE WERE NO OTHER DEFICIENT PRODUCTS USED DURING THE EVENT; THE CATHETER WAS NOT REPAIRED; THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT; AND, THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. SALINE SOLUTION WAS USED AS CLEANING AGENT TO CLEAN THE ENTIRE CATHETER; TEGO WAS NOT UTILIZED; THERE WAS NO BLOOD LOSS; BLOOD TRANSFUSION WAS NOT REQUIRED; THERE WAS NO LUER ADAPTER ISSUE; THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT; AND, NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS PERFORMED WITH SALINE SOLUTION; THERE WAS NO OTHER PRODUCT BEING UTILIZED WITH THE DEVICE; THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE ISSUE WAS OBSERVED; AND, REPOSITIONING OF ANOTHER CATHETER WAS DONE AS THE MEDICAL INTERVENTION TO THE PATIENT. THERE WAS NO OINTMENT UTILIZED WITH THE EXIT SITE; STERILE APOSITES WERE USED FOR THE WOUND DRESSING AND IT DID NOT INCLUDE ANY CLEANING AGEN

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10673561 ↗
• MalfunctionMay 28, 2020Break; Break

  ACCORDING TO THE REPORTER, IT WAS FOUND THAT THE CATHETER HAD A TEAR NEAR THE JUNCTION OF EXTERNAL CUFF. THIS EVENT OCCURRED WITHOUT ANY KNOWN SHARP OR ACCIDENTAL DAMAGE. CATHETER WAS NOT REPAIRED, POVIDONE IODINE USED AS A CLEANING AGENT ON THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10097425 ↗
• InjuryApr 13, 2020Migration or Expulsion of Device; Defective Component; Migration or Expulsion of Device; Defective Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THEY SAID THAT THE PERITONEAL CATHETER WAS FOUND DEFECTIVE, IT WAS STRETCHED OR NOT WELL-FORMED AND IT MOVED OUT OF ITS ORIGINAL INTENDED POSITION. THEY PLACED THE DEVICE AND THEY ARE NOT CONVINCED BY THE SHAPE, THEY SAID THAT THE CATHETER WAS SEEN TO MOVE INTO THE RIGHT QUADRANT ABOVE ILIAC CREST, OUT OF THE INSTALLED POSITION, LATER WHEN PERFORMING THE CATHETER TEST IT DID NOT WORK BECAUSE THEY TOOK ADVANTAGE OF THE POSITION WHERE THE INTERVENTIONIST PHYSICIAN INSTALLED IT. THE CATHETER DID NOT WORK, SO THE PATIENT TAKE LAXATIVE, EVEN SO IT DID NOT WORK, SO IT WAS NECESSARY TO REMOVE IT AND PLACE ANOTHER ONE. THE FLOW OF THE PERITONEAL FLUID WAS BEING TEST. A TITANIUM CONNECTOR WAS PLACED TO JOIN IT TO THE TRANSFER LINE AND LEAVE FULL PERITONEAL ACCESS, IT WAS SAID THAT THE CUFF WAS REMAINED ATTACHED TO THE SKIN TISSUE/ ENTRY POINT. RADIOGRAPH WAS PERFORMED TO TEST THE FUNCTIONALITY OF THE CATHETER AFTER PLACEMENT, THEY USED SALINE TO WET THE CATHETER AND THEY USED IODIZED SOAP FOR ASEPSIS OF THE ABDOMEN. THERE WAS NO BLOOD LOSS, THERE WAS NO CLEANING AGENT THAT WAS USED IN THE DEVICE NOR LUER ADAPTER ISSUE, CATHETER WAS NOT REPAIRED A

  Patient problems: Injury; No Information; Unintended Radiation Exposure

  MAUDE report 9952261 ↗