CARDINAL HEALTH
Received Dec 20, 2025 · Event occurred Mar 25, 2025
Report 3004824601-2025-00243 · MDR key 23858540
Device
Generic name
Snap Caps
Manufacturer
Citotest Labware Manufacturing Co.,Model number
CHB3035-82Lot number
230522
Product problems
- Difficult or Delayed Positioning
- Difficult or Delayed Positioning
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
THESE MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED PAST THE REGULATORY REPORTING TIMEFRAME AS THEY ARE A RESULT OF A RETROSPECTIVE REVIEW OF OUR COMPLAINTS. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THERE IS NO EVIDENCE TO INDICATE THAT THE EVENT RESULTED IN A SERIOUS INJURY. HOWEVER, THIS REPORT IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. ASP GLOBAL, IN COLLABORATION WITH ITS CONTRACT MANUFACTURER, COMPLETED THE INVESTIGATION FOR THIS COMPLAINT. THE INVESTIGATION INDICATED THAT THE RAW MATERIAL RESIN MAY NOT BE SUITABLE FOR REPETITIVE USE. AS A RESULT, A PRODUCT CHANGE WAS INITIATED TO EVALUATE AND IMPLEMENT AN ALTERNATIVE RESIN TYPE.
Description of Event or Problem
ON (B)(6) 2025, CUSTOMER REPORTED THAT PATIENTS WERE EXPERIENCING FINGER PAIN WHILE USING CHB3035-82 TOP SNAP CAP DUE TO THE CAPS BEING HARD TO FIT ON THE TUBE.