MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number 8888160341

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 08/19/2022

Event Type  malfunction  

Event Description

Certified registered nurse practitioner (crnp) and registered nurse (rn) at bedside for umbilical venous catheter (uvc) line insertion.Line insertion completed and x-ray completed.Imaging showed malpositioned uvc which noted tip of the catheter to the right midline likely within the portal vein.Two rns completed sterile line prep including prbcs.When primary rn went to connect sterile lines to the uvc catheter, rn noticed blood flowing back into the uvc line and leaking on to sterile prep field.The blood was not backing up through the blue microclave but was dripping out of part of the uvc catheter.Upon investigation, the uvc appeared to have a hole in the catheter.Crnp called to bedside.Uvc removed and new uvc placed.Faulty uvc catheter placed in bag and saved for further investigation of faulty product.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15369818
• MDR Text Key: 299378715
• Report Number: 15369818
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: 1803800115
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Female
• Patient Weight: 2 KG
• Patient Race: Black Or African American