VISTEC
Received Apr 14, 2025 · Event occurred Mar 25, 2025
Report 1423537-2025-00164 · MDR key 21836449
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health 200, LlcModel number
7317Catalog number
7317--
Lot number
24L021662
Product problems
- Material Separation
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE RAYTEC SPONGE WAS FOUND SHREDDED AND THE SPONGE PICKED AT AS IF IT WAS MESSED WITH, PROBABLY DURING THE PACKAGING PROCESS BY THE MANUFACTURER. THE CLINICIANS POURED STERILE WATER ON THE PRODUCT TO PREP FOR OPERATION, BUT NOTICED PARTICLES/SHREDDING FALLING FROM THE PRODUCT AND COULDN'T USE IT. THERE WAS NO HARM REPORTED.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD (DHR) FOR LOT 24L021662 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. ¿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 SAMPLES RETURNED FOR EVALUATION. INSTEAD, PHOTOS WERE PROVIDED AND THE REPORTED ISSUE WAS OBSERVED. HOWEVER, BASED ON THE AVAILABLE INFORMATION, AN EXACT ROOT CAUSE WAS NOT DETERMINED. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.