VISTEC
Received May 27, 2025
Report 1423537-2025-00213 · MDR key 22087653
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health 200, LlcModel number
7317Catalog number
7317--
Lot number
25B022962
Product problems
- Material Fragmentation
- Material Frayed
- Material Fragmentation
- Material Frayed
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CORRECTIONS: G2: REPORT SOURCE: DISTRIBUTOR WAS CHECKED OFF. D3: DATE RECEIVED BY MANUFACTURER WAS UPDATED FROM 15-MAY-2025 TO 08-MAY-2025.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED SHREDDING AND HIGH AMOUNTS OF LINT.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD (DHR) FOR LOT 25B022962 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. PHOTOS AND SAMPLES WERE PROVIDED FOR EVALUATION AND THE REPORTED ISSUE WAS CONFIRMED. HOWEVER, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. NO ACTIONS REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.