VISTEC
Received Apr 22, 2025 · Event occurred Apr 9, 2025
Report 1423537-2025-00171 · MDR key 21881206
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health 200, LlcModel number
7317Catalog number
7317--
Lot number
25B023062
Product problems
- Material Disintegration
- Material Disintegration
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE SPONGES ARE ¿SHEDDING¿, THEY ARE DROPPING SHREDS OF THE THIN FIBERS.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Additional Manufacturer Narrative
A NON-CONFORMANCE REVIEW WAS CONDUCTED FOR LOT 25B023062 AND THERE WERE NO NCS RELATED TO THE REPORTED EVENT ISSUED DURING THE MANUFACTURING OF THIS LOT. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. THERE WERE NO DEVICE(S) RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT(S) COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.