Argyle 8888160648 (UDI 20884527005199)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884527005199), received between Sep 23, 2020 and Jul 3, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT A 39.3 WEEK GESTATION INFANT WAS ADMITTED IN NEWBORN INTENSIVE CARE UNIT (NICU) FOR MECONIUM ASPIRATION WITH RESPIRATORY SYMPTOMS (MAS) AND WAS EMERGENTLY INTUBATED. A TRIPLE LUMEN CATHETER WAS PLACED IN THE INFANT BY A NEONATAL NURSE PRACTITIONER (NNP) AND WAS NOTED TO BE LEAKING CONSISTENTLY IN LINE (HOLE/CRACK IN IT). THE LINE WAS IMMEDIATELY REMOVED, AND ANOTHER LINE WAS PLACED. PER CUSTOMER, THERE WAS NO INJURY OR ADVERSE REACTION OCCURRED TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17248565 ↗
• MalfunctionOct 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PATIENT HAD A 5FR TRIPLE LUMEN UVC. THE FACILITY WAS UNABLE TO DRAW BLOOD OFF THE UVC AND AIR BUBBLES WERE NOTED WHEN ATTEMPTING TO DRAW OFF THE LINE. ALL THREE PORTS/LUMENS FLUSHED WELL. WHEN TPN/MEDICATION WAS REATTACHED TO THE UVC, LEAKING FLUID WAS NOTED WHERE THE LINE BIFURCATES TO THE THREE LUMENS. THE UVC WAS REMOVED ONCE A PICC LINE WAS INSERTED TO REPLACE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12635289 ↗
• MalfunctionJun 11, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER STATES THAT A CARDIAC PATIENT HAD A TRIPLE LUMEN UMBILICAL VESSEL CATHETER AND AFTER PLACEMENT, MULTIPLE FLUID BOLUSES AND DROPS WERE ORDERED. THE PROVIDERS REQUESTED THE BEDSIDE NURSE HAND PUSH BOLUSES INSTEAD OF RUNNING THEM ON A PUMP. THE NURSES HAD A HARD TIME PUSHING THE MEDS BECAUSE THERE WAS A LOT OF RESISTANCE. IT WAS DISCOVERED THAT THERE WAS A CRACK IN THE TERTIARY LUMEN AFTER THE ECHO TECH FELT THE FLUID FROM THE BOLUSES SPLASHING HIM. THE NEONATAL NURSE PRACTITIONER WAS NOTIFIED, AND REPLACED THE TRIPLE LUMEN UMBILICAL VESSEL CATHETER WITH ANOTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986376 ↗
• MalfunctionSep 23, 2020Break; Break

  THE CUSTOMER REPORTED THAT THERE IS A BREAK/TEAR/HOLE AT APPROXIMATELY 10 CM MARK. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER AND IT WAS STATED THAT A HOLE WAS DISCOVERED, WHEN A X-RAY WAS TAKEN TO CONFIRM THE CATHETER PLACEMENT, AFTER INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10575619 ↗