MAUDE Adverse Event Report: COOK, INC. COOK MEDICAL RADIAL ARTERY CATHETER SET, 3 FR./5 CM REFERENCE NUMBER CPMS-300-RA; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number C-PMS-300-RA

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2021

Event Type  Injury  

Event Description

Two catheters broke for surgery on a patient.One catheter broke at the hub and the catheter was dislodged in the patient.Surgical intervention was required to retrieve the product.Cook medical radial artery catheter set, 3 fr./5 cm reference number cpms-300-ra; reference number g01908; lot 9938161.Expiration date: 08/08/2022.The other catheter broke prior to entering it in the patient.In preparation to place another arterial line, this catheter was broken at the hub as well.Cook radial artery catheter set, 3 fr./5 cm reference number c-pms-300-ra; reference number g01908; lot number 9285137.Expiration date: 11/02/2021.Fda safety report id# (b)(4).

• Brand Name: COOK MEDICAL RADIAL ARTERY CATHETER SET, 3 FR./5 CM REFERENCE NUMBER CPMS-300-RA
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402 0489
• MDR Report Key: 12336852
• MDR Text Key: 267281064
• Report Number: MW5103305
• 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: 08/13/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C-PMS-300-RA
• Device Catalogue Number: G01908
• Device Lot Number: 993816
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention