MAUDE Adverse Event Report: ARROW INTERNATIONAL ARROW RADIAL ARTERY CATHEERIZATION SET; ARROW RADIAL ARTERY CATHETERIZATION SET

Model Number RA-04020

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2017

Event Type  malfunction  

Event Description

There was resistance upon threading the wire through the radial arterial catheter.It was however placed without using a second kit.When the physician removed the set-up from patient's wrist, the needle detached and fell off outside the patient.No harm to patient.There was the potential for needle stick injury or shearing of the wire off inside of the patient.

• Brand Name: ARROW RADIAL ARTERY CATHEERIZATION SET
• Type of Device: ARROW RADIAL ARTERY CATHETERIZATION SET
• Manufacturer (Section D): ARROW INTERNATIONAL
• MDR Report Key: 6701194
• MDR Text Key: 79801930
• Report Number: MW5070901
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2021
• Device Model Number: RA-04020
• Device Catalogue Number: RA-04020
• Device Lot Number: 14F17A0058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• 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