VISTEC
Received Sep 12, 2025 · Event occurred Aug 19, 2025
Report 1423537-2025-00364 · MDR key 23042631
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health 200, LlcModel number
7317Catalog number
7317--
Lot number
25C055462
Product problems
- Component Missing
- Component Missing
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 PICTURES AND THE SAMPLES PROVIDED, THE REPORTED ISSUE WAS OBSERVED. THE EXACT ROOT CAUSE WAS NOT DETERMINED AND BASED ON ALL AVAILABLE INFORMATION, THIS IS BELIEVED TO HAVE BEEN AN ISOLATED EVENT 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 TWO ONLY HAD 9 IN THE PACKAGE.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. UDI PI PENDING AND WILL BE ADDED WHEN AVAILABLE.