MAUDE Adverse Event Report: ARROW ARROW 20 G. X 1-3/4" (4.4CM) RADIAL ARTERY CATHERIZATION SET

Model Number RA-04020

Device Problems Failure to Advance (2524); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2015

Event Type  malfunction  

Event Description

Two radial artery catheterization sets (ara a-line darts).Both with the markings 14f15do416 (b)(4), ref ra-04020, a-04020- (b)(4) (08/11).Both lines would cannulate the radial artery but the built in wires would not advance into the vessel.They made a clicking noise as they were advanced approx 1cm and then they would give a grinding feeling as we tried to advance the wires.Thankfully the wires were not advanced into the patient.Still they were defective and could have broken off inside the patient.The packaging w/ the markings was given to the icu charge nurse.

• Brand Name: ARROW 20 G. X 1-3/4" (4.4CM) RADIAL ARTERY CATHERIZATION SET
• Type of Device: CATHERIZATION SET
• Manufacturer (Section D): ARROW; reading PA
• MDR Report Key: 4875021
• MDR Text Key: 5862340
• Report Number: MW5043256
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: RA-04020
• Device Catalogue Number: RA-04020
• Device Lot Number: 14F15DO416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1