MAUDE Adverse Event Report: COVIDIEN MANUFACTURING SOLUTIONS SA ARGYLE POLYURETHANE; CATHETER, UMBILICAL ARTERY

Lot Number 1916800103

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Blood Loss (2597)

Event Date 11/11/2019

Event Type  malfunction  

Event Description

Neonatal fellow was removing umbilical artery vessel catheter after discontinuation of fluids from umbilical artery.Per fellow, she cut the sutures and peeled away the part of the umbilical artery that had adhered to the catheter.The umbilical vein vessel catheter was removed first and without incidence.While slowly removing the catheter with the catheter between her thumb and forefinger.The first 7 cm of the catheter was able to be pulled out of the vessel without difficulty.While attempting to remove the last 5 cm of the catheter, the catheter broke off at the umbilical stump.Pressure was immediately applied to the site and a hemostat was used to stop blood loss.A stat x-ray and surgical consult were done.After viewing the x-ray, surgery was able to remove the remaining catheter via the remaining umbilical stump.Estimated blood loss at 12 milliliters.Patient received normal saline (nss) bolus during procedure.

• Brand Name: ARGYLE POLYURETHANE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN MANUFACTURING SOLUTIONS SA; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 9375262
• MDR Text Key: 168052096
• Report Number: 9375262
• 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: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1916800103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2019
• Date Report to Manufacturer: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 DA