BLOX
Received Apr 8, 2026 · Event occurred Mar 10, 2026
Report 3005099803-2026-01266 · MDR key 24818361
Device
Generic name
Endoscopic Bite Block
Manufacturer
Jiangsu Jianyu Health Medical Co LtdModel number
SBT-114-100Catalog number
SBT-114-100
Lot number
0000250802
Product problems
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: DEVICE CODE A1802 CAPTURES THE REPORTABLE EVENT OF FOREIGN MATERIAL PRESENT IN THE PACKAGING.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING PREPARATION FOR AN UPPER ENDOSCOPY ON (B)(6) 2026, IT WAS NOTED IN THE UNOPENED BITE BLOX PACKAGE THERE WAS DIRT ON THE WHITE STRAP. THERE WAS NO PATIENT INVOLVEMENT AT THIS TIME. A NEW BITE BLOX WAS OPENED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.