SOFT TISSUE BIOPSY TRAY
Received Jun 1, 2026 · Event occurred May 5, 2026
Report 1423507-2026-00078 · MDR key 25348718
Device
Product problems
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. A PHOTO WAS PROVIDED FOR REVIEW. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
Description of Event or Problem
IT WAS REPORTED THAT THE PRODUCT CAME IN WITH FILM ALL OVER THE PACKAGE, LIKE A DETERGENT. DURING FOLLOW UP IT WAS FURTHER REPORTED THE PRODUCT WAS IN REPACK BOX AND THE PACKAGES WERE RECEIVED WITH LIQUID SUBSTANCE. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.