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

Model Number 8888160432

Device Problems Break (1069); Crack (1135); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2020

Event Type  malfunction  

Event Description

Umbilical vessel catheter (uvc) placed on infant following delivery.No insertion complications noted.The procedure note reported blood was withdrawn easily and the catheter flushed without difficulty.Imaging showed the placement in the right hepatic lobe.Repositioning was needed.Staff report the catheter broken after being "pulled back to a low-lying line." per the procedure note, after insertion the catheter noted to be cracked at the hub, but upon further assessment staff noted the catheter was split in half with only the radiopaque line holding it together.The uvc was removed.Argyle 5fr.Uvc (polyurethane catheter).Secured with suture at 11cm.Dwell time: less than 10 minutes.Manufacturer response for vascular, argyle (per site reporter).Yes, representative is aware and investigating.Informed that catheter is available to return.At the time of this report, it is unknown to this writer if catheter has been returned.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 300 south riverside plaza; chicago IL 60606
• MDR Report Key: 9670483
• MDR Text Key: 177799151
• Report Number: 9670483
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8888160432
• Device Catalogue Number: 8888160432
• Device Lot Number: 1906400173
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 3