MAUDE Adverse Event Report: COVIDIEN / CARDINAL HEALTH COSTA RICA, S.A. COVIDIEN ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY; CATHETER, UMBILICAL ARTERY

Catalog Number 888160432

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/27/2021

Event Type  malfunction  

Event Description

Umbilical artery catheter (uac) fragment (15.5 cm in length) incidentally identified in (b)(6) neonatal intensive care unit (nicu) pt's aorta on imaging.Rn removed catheter and noted it was not intact, the markings indicated there was 15cm missing.Uac was inserted at another hospital.

• Brand Name: COVIDIEN ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN / CARDINAL HEALTH COSTA RICA, S.A.
• MDR Report Key: 11812153
• MDR Text Key: 250415007
• Report Number: MW5101306
• Device Sequence Number: 1
• Product Code: FOS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 888160432
• Device Lot Number: 2102200111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 DA
• Patient Weight: 2