NRFIT CSE PAIN MANAGEMENT TRAYS
Received Nov 11, 2025 · Event occurred Sep 1, 2025
Report 3012307300-2025-12315 · MDR key 23522617
Device
Generic name
Combined Spinal Epidural
Manufacturer
Icu Medical, Inc.Catalog number
NCC6160CJP
Lot number
UNKNOWN
Product problems
- Complete Blockage
- Complete Blockage
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
RECEIVED ONE DEVICE. VISUAL INSPECTION FOUND NO DAMAGE. THE FLAT FILTER WAS RETURNED WITH SYRINGE. UPON INSPECTION OF THE FILTER, NO OBVIOUS ABNORMALITIES WERE FOUND. UPON INSPECTING THE APPEARANCE OF THE FLAT FILTER THAT WAS RETURNED TO US, WE FOUND THAT THERE WAS AIR AND LIQUID INSIDE THE FILTER. TO CHECK ITS FUNCTIONALITY, WE INJECTED WATER INTO THE FILTER AND CONFIRMED THAT WATER FLOWED OUT THE TIP WITHOUT ANY PROBLEMS. SINCE AIR WAS FOUND INSIDE THE FLAT FILTER WHEN WE RECEIVED IT, IT IS POSSIBLE THAT A TEMPORARY AIRLOCK HAD OCCURRED. NO LOT NUMBER WAS PROVIDED; THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED.
Description of Event or Problem
IT WAS STATED THAT THE LIQUID IS NOT PASSING THROUGH THE FILTER. NO PATIENT INVOLVEMENT.