MAUDE Adverse Event Report: COOK INC. COOK FEMORAL A LINE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/26/2021

Event Type  malfunction  

Event Description

Femoral aline noted to be leaking profusely after pt.Supine.Dressing taken down and blood noted to be spurting from a spot in the aline catheter.Aline removed and catheter and tubing piece changed.Pt was very sick and a 3rd pressor was being initiated.We had to use nibp for pressor titration which was suboptimal.A-line tubing taken to risk.Unsure if line was punctured when being placed by md.Patient was being prone and supine.If line was punctured with suture while placing it may not have been noticed initially but with turning, wonder if it pulled out a little and then leak was seen.This was a femoral line and it was very difficult to place.They were unable to place a radial, so femoral done with much difficulty.Fda safety report id # (b)(4).

• Brand Name: COOK FEMORAL A LINE
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC.; bloomington IN 47402
• MDR Report Key: 11783054
• MDR Text Key: 249499757
• Report Number: MW5101194
• Device Sequence Number: 1
• Product Code: DQO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: 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 Age: 63 YR