FDA Adverse Event Malfunction Summary report: N

ARROW

MDR report key: 23509490 · Received November 10, 2025

Report

Report Number
23509490
Event Type
Malfunction
Date Received
November 10, 2025
Date of Event
September 10, 2025
Report Date
September 17, 2025
Manufacturer
TELEFLEX MEDICAL LLC
Product Code
DQY
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IA
Reporter Occupation
NURSE
Health Professional
Yes

Narratives

Description of Event or Problem · 0

THE NURSE WAS DRAWING LABS FROM THE ARTERIAL CATHETER. FOLLOWING THE PROCEDURE, THE NURSE TURNED THE ARTERIAL LINE OFF TO THE FLUSH BAG AND ATTACHED SYRINGE WITH BLUNT TIP TO THE UPPER SAMPLING PORT. THE NURSE BEGAN TO ASPIRATE THE WASTE AND NOTICED THE SAMPLE APPEARED FOAMY. AS THE NURSE WITHDREW THE SYRINGE FROM THE SAMPLING PORT, BLOOD WAS VISIBLE ON THE PORT. THE NURSE PROCEEDED TO OBTAIN THE SPECIMEN BY ATTACHING A 10ML SYRINGE WITH BLUNT TIP TO THE LOWER SAMPLING PORT. AS THE NURSE ASPIRATED, THE SAMPLE WAS FOAMY AND MIXTURE OF BLOOD AND AIR. WHEN THE SYRINGE WAS WITHDRAWN, BLOOD LEAKED FROM THE PORT. THE NURSE CONFIRMED THERE WAS NO AIR VISIBLE IN THE HIGH-PRESSURE TUBING, THE HIGH-PRESSURE BAG WAS INFLATED TO 300 MM HG [MILLIMETERS OF MERCURY], ALL ACCESS PORTS HAD SOLID CAPS, AND CONNECTIONS ALL TIGHTENED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2436156 ARROW CATHETER, PERCUTANEOUS DQY TELEFLEX MEDICAL LLC IPN920735

Patients

Seq Age Sex Outcome Treatment
1 NA Male