ARROW THORACENTESIS KIT
Received Dec 1, 2025 · Event occurred Oct 6, 2025
Report 9680794-2025-00983 · MDR key 23678149
Device
Generic name
Catheter And Tip Suction
Manufacturer
Arrow International LlcCatalog number
AK-01000
Lot number
33F25C0905
Product problems
- Obstruction of Flow
- Obstruction of Flow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
Description of Event or Problem
IT WAS REPORTED THAT: "ONE WAY VALVE MALFUNCTIONED, COULD NOT DRAIN FLUID INTO COLLECTING BAG. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT: "ONE WAY VALVE MALFUNCTIONED, COULD NOT DRAIN FLUID INTO COLLECTING BAG. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."