ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM
Received Sep 16, 2025 · Event occurred Aug 19, 2025
Report 3006425876-2025-00837 · MDR key 23063032
Device
Generic name
Catheter Hemodialytsis Non Imp
Manufacturer
Arrow International LlcCatalog number
CS-25142-F
Lot number
71F24G0784
Product problems
- Material Twisted/Bent
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT "SWG BENT." THE DEVICE WAS REPLACED. THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
QN# (B)(4). UPON INVESTIGATION OF THE RETURNED SAMPLE, IT WAS FOUND THAT THE MALFUNCTION WAS NOT REPORTABLE; THUS THE INITIAL MDR, SUBMITTED ON 09/16/2025, SHOULD BE RETRACTED.
Description of Event or Problem
IT WAS REPORTED THAT "SWG BENT." THE DEVICE WAS REPLACED. THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.