VISTEC
Received Sep 12, 2025 · Event occurred Aug 19, 2025
Report 1423537-2025-00365 · MDR key 23042637
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health 200, LlcModel number
7317Catalog number
7317--
Lot number
25C055462
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD (DHR) FOR LOT 25C055462 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. BASED ON THE SAMPLES PROVIDED, THE REPORTED ISSUE WAS OBSERVED. HOWEVER THE EXACT ROOT CAUSE WAS NOT DETERMINED BUT IS MOST LIKELY RELATED TO THE MANUFACTURING PROCESS. THIS COULD HAVE BEEN AN ISOLATED EVENT INCIDENT AS THERE WERE NO ISSUES IDENTIFIED AS PART OF THE IN-PROCESS INSPECTIONS THEREFORE NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. WE WILL CONTINUE TO MONITOR REPORTS AND TAKE ACTIONS AS APPLICABLE.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE PRODUCT IS LINTING REALLY BAD.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. UDI PI PENDING AND WILL BE ADDED WHEN AVAILABLE.