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

Lot Number 1806700165

Device Problem Leak/Splash (1354)

Patient Problems Vomiting (2144); Irritability (2421)

Event Date 07/29/2018

Event Type  malfunction  

Event Description

Male infant delivered. Thick meconium noted at delivery. Admitted to nicu for respiratory distress, cyanosis and high risk of infection. Coviden argyle umbilical venous catheter (uvc) 5fr, single lumen, 25cm placed after birth. Skin cleaned with chlorhexidine. Uvc initially secured at 13cm but after x-ray, pulled back to 11cm. Secured with suture. Two days after insertion, the infant had an episode of spitting up and became irritable. During this event, the nurse noted blood backing up in the uvc line. Then the rn noted that the catheter was leaking. The uvc was removed. No injury noted to the patient. Uvc: argyle 5 fr. , 25cm, single lumen.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 7893219
• MDR Text Key: 120861022
• Report Number: 7893219
• 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

• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: 1806700165
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage