ULTRACORE BIOPSY NEEDLE 18GA X 16CM

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.

Description of Event or Problem

PERCUTANEOUS LUNG BIOPSY WAS PERFORMED IN THE CT ROOM OF THE RADIOTHERAPY DEPARTMENT. POSTOPERATIVE CT IMAGES SHOWED THAT THE PATIENT DEVELOPED A SMALL AMOUNT OF PNEUMOTHORAX. FIVE MINUTES LATER, A CHEST CT SCAN WAS PERFORMED, AND THE CT IMAGES SHOWED NO SIGNIFICANT CHANGES IN PNEUMOTHORAX. AFTER THE SURGERY, THE PATIENT RETURNED TO THE WARD SAFELY. THE SAMPLE COULD NOT BE TAKEN OUT.

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. CORRECTED INFORMATION PROVIDED IN H.6. AND H.11.