ULTRACORE BIOPSY NEEDLE 18GA X 16CM

Description of Event or Problem

THE PATIENT UNDERWENT CT GUIDED BIOPSY OF A SPACE OCCUPYING LESION IN THE UPPER LOBE OF THE RIGHT LUNG IN THE CT ROOM OF THE RADIOTHERAPY DEPARTMENT. A TOTAL OF 3 GRAY RED AND GRAY BLACK TISSUES WERE OBTAINED, SOME OF WHICH WERE FRAGMENTED AND HAD A SIZE OF APPROXIMATELY 0.5-1.0 × 0.1CM. THE SPECIMENS WERE FIXED IN 10% FORMALIN SOLUTION AND SENT TO THE PATHOLOGY DEPARTMENT FOR CYTOLOGICAL EXAMINATION. THE COAXIAL PUNCTURE NEEDLE WAS REMOVED AND THE PUNCTURE SITE WAS WRAPPED AND FIXED. CT RE EXAMINATION SHOWED NO EXUDATION IN THE PUNCTURE SITE, MODERATE PNEUMOTHORAX ON THE RIGHT SIDE, AND NO PLEURAL EFFUSION.

Additional Manufacturer Narrative

THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON INVESTIGATION COMPLETION.

Additional Manufacturer Narrative

A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT WAS CONDUCTED. NO DEVIATIONS OR NON-CONFORMANCES WERE FOUND. THE CUSTOMER DID NOT RETURN ANY SAMPLES FOR EVALUATION. ADDITIONALLY, NO PHOTOGRAPHIC OR VISUAL EVIDENCE WAS SUBMITTED THAT WOULD HAVE ALLOWED THIS ALLEGATION TO BE REVIEWED. WITHOUT THE NECESSARY EVIDENCE, A THOROUGH INVESTIGATION CANNOT BE PERFORMED. DETERMINING A ROOT CAUSE AND CORRECTIVE ACTION IS NOT POSSIBLE. NO CORRECTIVE ACTION IS REQUIRED AT THIS POINT. IF THE SAMPLES ARE RETURNED AT A LATER DATE, THEN THIS COMPLAINT MAY BE REOPENED FOR RE-EVALUATION. ADDITIONAL INFORMATION PROVIDED IN H.6. AND H.11.