Argyle 8888160556 (UDI 20884527005182)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20884527005182), received between Jan 7, 2020 and Mar 20, 2025 — classified as 1 death, 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2025Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE UMBILICAL VEIN CATHETER (UVC) WAS PLACED AS THEY WERE UNABLE TO OBTAIN PERIPHERAL INTRAVENOUS (PIV) ACCESS. THE UVC WAS PLACED, AND INFANT TOLERATED THE PROCEDURE WELL. WHEN THE REGISTERED NURSE (RN) WENT TO HOOK UP FLUIDS TO THE UVC PRIMARY HUB, THE IV TUBING WOULD CONNECT, BUT NOT SCREW ON. IT JUST KEPT TURNING AND NOT SCREW ON TIGHTLY. THE RN TRIED TO SCREW THE IV FLUIDS ON TO THE SECONDARY LUMEN HUB AND THE IV FLUIDS WOULD ALSO NOT SCREW ON PROPERLY BUT WERE TIGHTER THAN THE PRIMARY LUMEN HUB. NEONATAL NURSE PRACTITIONER (NNP) CALLED TO THE BEDSIDE AND THE SITUATION WAS EXPLAINED. NNP STUDENT WHO PLACED THE UVC STATED THAT HE DIDN'T NOTICE ANY DIFFICULTY WHEN SCREWING ON A SYRINGE TO DRAW LABS AND VERIFY UVC PLACEMENT. UPON FURTHER INVESTIGATION, IT LOOKED LIKE THERE WERE "RIDGES" ON THE PRIMARY HUB THAT PREVENTED IV FLUIDS FROM BEING TIGHTENED PROPERLY. IT WAS DECIDED THAT THEY WOULD NOT USE THE PRIMARY HUB, AND IT WAS TAPED OFF, SO ALL OTHER STAFF KNEW NOT TO USE. AS FOR THE SECONDARY, A CLAVE WAS PLACED TO HELP MAKE THE CONNECTION TIGHTER, AND IV FLUIDS WERE BEING RAN THROUGH THE SECONDARY LUMEN. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654227 ↗
• MalfunctionNov 7, 2024Break; Connection Problem; Break; Connection Problem

  THE CUSTOMER REPORTED THAT THEY WERE NOT ABLE TO SECURELY ATTACH THE TUBING OR CLAVE TO UMBILICAL CATHETER HUB. PER CUSTOMER, THEY HAD PREVIOUSLY BEEN ABLE TO SECURE TUBING. THE CUSTOMER FURTHER STATED THAT WHEN THE LINE WAS REMOVED, THE HUB OF LINE FOUND TO BE BROKEN. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631678 ↗
• MalfunctionOct 15, 2024Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  THE CUSTOMER REPORTED THAT THE CONNECTER DOESN'T HAVE A LIP TO SEED THE CONNECTION, SO IT CAN'T CONNECT TO A CLAVE PROPERLY WITHOUT LEAKING. THE ISSUE WAS DISCOVERED BEFORE USE. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453476 ↗
• MalfunctionJul 24, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT WHAT USED TO BE ROUNDED EDGES AT THE END OF THE PORTS NOW HAVE (WHAT THEY WILL CALL) AS TABS ON THE RIGHT AND LEFT SIDES. IF ONE OR BOTH OF THESE TABS GETS WORN DOWN, THE STOPCOCK THAT THEY ROUTINELY CHANGE DOES NOT SCREW ON SECURELY ANYMORE, RESULTING IN PATIENT SAFETY RISK AND THE UMBILICAL LINE HAD TO BE REMOVED AND A NEW TYPE OF INTRAVENOUS ACCESS OBTAINED. THIS UMBILICAL LINE WAS ONLY IN USE FOR 5 DAYS (SHOULD LAST UP TO 14 DAYS OR LONGER) BEFORE THIS ISSUE AROSE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19821948 ↗
• MalfunctionJul 17, 2024Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT A FAULTY DUAL LUMEN UVC WAS FOUND DURING LINE PLACEMENT. PER CUSTOMER, INFANT TO RECEIVE A DUAL LUMEN UVC AND ADVANCED PRACTICE PROVIDER (APP) WAS UNABLE TO FLUSH HEPARINIZED SALINE THROUGH BLUE (SECONDARY) LUMEN. NEW CATHETER UTILIZED SUCCESSFULLY. THERE WAS NO HARM REPORTED TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761143 ↗
• MalfunctionJul 9, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THEY HAD TWO ISSUES IN OUR NICU DEPARTMENT INVOLVING THE ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER. THE INCONSISTENT DEPTH OF THE RING THAT LOCKS THIS CATHETER TO BREAK APART ON THIS LOT. FOR CLARIFICATION, WHERE YOU CONNECT THE TUBE/PARTS TOGETHER, IS NOT HOLDING TOGETHER. THE NURSE HAD TO REPLACE THE LINE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705314 ↗
• MalfunctionMar 29, 2024Break; Break

  CUSTOMER REPORTS: THE DEVICE WAS FOUND CRACKED WHEN THEY OPENED THE PRODUCT PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003714 ↗
• MalfunctionMar 30, 2022Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  THE CUSTOMER REPORTED THAT THE LINES HAD AIR WHEN ASPIRATING BOTH IN VEINS AND ARTERIES WITH SOLUTION COMING OUT OF ONE SIDE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13954766 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED AN INCIDENT INVOLVING A (B)(6) OLD TERM BABY. A 5F DUAL LUMEN UMBILICAL VESSEL CATHETER (UVC) WAS PLACED AT DELIVERY ON (B)(6) 2021 WITH NO DIFFICULTY AND GOOD POSITION. THE UVC WAS SECURED BY TAPE BRIDGE. TPN AND PGE WERE INFUSING. ON (B)(6) 2021 AT (B)(6) OLD, TWO FAIRLY LARGE PLEURAL EFFUSIONS OF UNKNOWN ETIOLOGY WERE DISCOVERED. THE PATIENT WAS EMERGENTLY INTUBATED AND CHEST TUBES WERE PLACED BILATERALLY THAT SAME DAY. A SAMPLE WAS OBTAINED FROM THE CHEST TUBES AND SENT TO THE LAB. THE SAMPLE TESTED POSITIVE FOR EXTREMELY HIGH GLUCOSE AND TRIGLYCERIDES. THAT SAME DAY AN ECHO WAS DONE AND VERIFIED PERICARDIAL EFFUSION SO A PERICARDIOCENTESIS WAS DONE AND FLUID WAS OBTAINED FROM THE PERICARDIAL SPACE. THIS FLUID WAS ALSO SENT OFF TO LAB AND CONFIRMED TO HAVE HIGH LEVELS OF GLUCOSE AND TRIGLYCERIDES. BOTH FLUIDS WERE LATER DETERMINED TO BE TPN AND LIPIDS INFUSING THROUGH THE UVC. THE PATIENT IS CURRENTLY IN THE ICU. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pericardial Effusion; Pleural Effusion

  MAUDE report 12051257 ↗
• DeathJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A PREMATURE BABY ON DAY OF LIFE (DOL) ONE DEVELOPED WORSENING DISCOLORATION OF HIS ABDOMEN AND TESTES AND ABDOMINAL DISTENTION ON (B)(6) 2021. AFTER EVALUATION BY SURGICAL SERVICES AND AN ABDOMINAL ULTRASOUND, FLUID WAS NOTED IN THE ABDOMEN. THERE WERE NO COMPLICATIONS PLACING OR SECURING THE UMBILICAL VESSEL CATHETER DUAL LUMEN (UVC) OTHER THAN IT BEING IN A LOW LYING POSITION WHICH WAS SECURED BY TAPE BRIDGE ON (B)(6) 2021. XRAY COMMENTED ON ABNORMAL PATH ON THE INITIAL READ, THOUGH IT DREW BLOOD. A REPLACEMENT OF THE UVC WAS ATTEMPTED WITH A NEW DEVICE JUST AFTER BIRTH IN THE DELIVERY ROOM. THAT SAME DAY THEY ATTEMPTED REPLACEMENT AGAIN IN THE NICU WITH A NEW DEVICE BECAUSE OF UNRESPONSIVENESS TO PRESSORS (5F DL). THEY WERE CONCERNED THAT THE PRESSORS WERE NOT WORKING. THE UVC WAS FOUND TO BE LOW LYING AGAIN AND WAS SECURED IN THE LOW LYING POSITION. A STAT ABDOMINAL ULTRASOUND WAS PERFORMED. THERE WAS CONCERN FOR THE UVC ERODING THROUGH THE VESSEL. INFUSATES WERE DOPAMINE, BLOOD, FFP, TPN/IL. CONCERN WAS RAISED BY THE SURGICAL TEAM THAT THE PATIENT MAY HAVE HAD AN INJURY DURING THE INITIAL UVC PLACEMENT AND IN THE SETTING OF COAGULOPATHY CAUSED INJURY

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

  MAUDE report 12050289 ↗
• InjuryDec 13, 2020Break; Break

  THE CUSTOMER REPORTED THAT WHILE CHECKING FOR RESISTANCE, THE CATHETER SNAPPED CAUSING +- 10 CM TO BE RETAINED WITHIN THE PATIENT. ADDITIONAL INFORMATION PROVIDED ON 2-DEC-2020 STATED THAT THE PATIENT HAD TO BE REFERRED TO A CARDIOLOGIST IN (B)(6) TO UNDERGO OPEN HEART SURGERY TO REMOVE THE CATHETER. IT SNAPPED AT THE 10CM MARK JUST OUTSIDE THE UMBILICAL CORD AS THEY TESTED FOR RESISTANCE. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 8-DEC-2020 STATED THAT CHLORHEXIDINE/SALINE WAS USED TO CLEAN THE AREA PRIOR TO INSERTION. THE AREA WAS COMPLETELY DRY PRIOR TO INSERTION ON (B)(6) 2020 INTO THE UVC. IT WAS SECURED WITH 3.0 STITCHES AND TO THE RESPONDER'S KNOWLEDGE IT WAS NOT DIFFICULT TO SECURE. THE LINE WAS FLUSHED ON A REGULAR BASIS WITH NEOCYTE INFUSION/WATER FOR INJECTION BEFORE INSERTION, NEOCYTE INFUSION AFTER INSERTION. CHLORHEXIDINE/SALINE WAS USED TO CLEAN THE CORD. WEBCOL ON THE HUB. THE UVC BROKE ON (B)(6) 2020, AND THE RETAINED UVC WAS SURGICALLY REMOVED ON (B)(6) 2020. THE DEVICE WAS NOT REPLACED. BESIDES THE RETAINMENT THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL MEDICAL INTERVENTION REQUIRED WAS INTUBATION, VENTILATION, AFTER EXTUBATION, OXYGEN THERAPY, PERICAR

  Patient problems: Foreign Body In Patient

  MAUDE report 10998506 ↗
• MalfunctionJun 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT ONE OF THE UMBILICAL CATHETER LUMEN WAS PULLED OUT OF THE ADAPTER/CONNECTOR WHILE INSERTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BETADINE WAS USED TO CLEAN THE SKIN AREA AND WAS COMPLETELY DRIED PRIOR TO INSERTION. IT WAS NOT DIFFICULT TO HANDLE THE CATHETER DURING INSERTION AND WAS NOT DIFFICULT TO SECURE. IT WAS SECURED USING SUTURE AND TEGADERM. IT WAS INSERTED ON (B)(6) 2020 IN THE UVL. THE LINE WAS NOT FLUSHED ON A REGULAR BASIS, IT WAS USED CONTINUOUSLY. THERE WAS A TUBING CONNECTIONS UP HIGH IT HAD ALCOHOL CAPS ON PORTS. THIS WAS DISTAL TO LINE INSERTION SITE. THE UVC WAS REMOVED ON (B)(6) 2020. IT WAS REPLACE WITH A NEW UVC. THERE WAS NO ISSUE WITH THE PATIENT. THE PATIENT IS (B)(6) GESTATION, (B)(6) AND THE HEALTH STATUS PRIOR TO THE EVENT WAS STABLE. THERE WAS NO SIGN OF DISTRESS OR COMPLICATIONS RELATED TO THE EVENT. THE CURRENT PATIENT STATUS IS STABLE AND NO FOLLOW UP CARE IS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10165796 ↗
• MalfunctionFeb 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE NURSE PRACTITIONER WAS ADJUSTING PLACEMENT OF AN UMBILICAL VENOUS CATHETER AND NOTICED THAT THERE WAS A DROP OF IV FLUID ESCAPING FROM THE SIDE OF THE UMBILICAL CATHETER. THE POINT WHERE THE FLUID WAS LEAKING WAS CLOSE TO WHERE THE LINE WAS SUTURED; THE NURSE PRACTITIONER NOTICED THAT THE SUTURE WAS QUITE TIGHT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9660891 ↗
• InjuryJan 7, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE LINE WAS DUE TO BE CHANGED. THE FLASH RN WAS TRYING TO FLUSH THE LINE AT THE MAX ZERO AND THE LINE STARTED LEAKING THROUGH THE UMBILICUS WHILE SHE FLUSHED IT. BOTH LUMENS WERE THE SAME. THE NURSE CALLED THE NNP. THE NNP CAME TO BEDSIDE AND ORDERED X-RAY. PIV WAS STARTED BY THE RN. THE PATIENT'S GLUCOSE WAS CHECKED AND WAS 38. D10W BOLUS WAS GIVEN. THEY STARTED IV FLUIDS VIA IV. THE UVC WAS CLAMPED AND PICC WAS PLACED TO RUN D30/TPN/IL.

  Patient problems: Hypoglycemia

  MAUDE report 9560342 ↗