SAFETY SOFT TISSUE BIOPSY TRAY
Received Jun 25, 2025 · Event occurred May 20, 2025
Report 1625685-2025-00058 · MDR key 22332749
Device
Product problems
- Contamination
- Contamination
Patient
73 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT SOME FOREIGN MATERIAL WAS FOUND IN THE STERILE SAFETY SOFT TISSUE BIOPSY TRAY. IT WAS FURTHER REPORTED THAT ON ASSESSMENT AFTERWARD NURSING MANAGER PALPATED DEBRIS AND DESCRIBED IT AS " HARD, LIKE CARDBOARD".
Additional Manufacturer Narrative
H11: G3 (DATE RECEIVED BY MANUFACTURER), G6 TYPE OR REPORT - FOLLOW UP# 1), H2 (CORRECTION AND ADDITIONAL INFORMATION), H3 (DEVICE EVAL BY MANUFACTURER) A DEVICE WAS NOT RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, ANOTHER 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.
Additional Manufacturer Narrative
H11: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. G3 (DATE RECEIVED BY MANUFACTURER), G6 TYPE OR REPORT - FOLLOW UP# 2), H2 (CORRECTION AND ADDITIONAL INFORMATION), H4 (DEVICE MANUFACTURING DATE IS UNKNOWN), H6 (ANNEX G ¿ COMPONENT CODE), ANNEX B (TYPE OF INVESTIGATION), ANNEX C (INVESTIGATION FINDINGS), ANNEX D (INVESTIGATION CONCLUSIONS). 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 SOME FOREIGN MATERIAL WAS FOUND IN THE STERILE SAFETY SOFT TISSUE BIOPSY TRAY. IT WAS FURTHER REPORTED THAT ON ASSESSMENT AFTERWARD NURSING MANAGER PALPATED DEBRIS AND DESCRIBED IT AS " HARD, LIKE CARDBOARD".
Description of Event or Problem
IT WAS REPORTED THAT SOME FOREIGN MATERIAL WAS FOUND IN THE STERILE SAFETY SOFT TISSUE BIOPSY TRAY. IT WAS FURTHER REPORTED THAT ON ASSESSMENT AFTERWARD NURSING MANAGER PALPATED DEBRIS AND DESCRIBED IT AS " HARD, LIKE CARDBOARD".
Additional Manufacturer Narrative
H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS HAS NOT BEEN PERFORMED. THE DEVICE IS PENDING RETURN. THE INVESTIGATION IS CURRENTLY UNDERWAY. H11: 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.