ULTRACORE BIOPSY NEEDLE 18GA X 16CM
Received Dec 12, 2024 · Event occurred Oct 29, 2024
Report 0001625425-2024-01170 · MDR key 20913907
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
55 YR · Female
- Hemorrhage/Blood Loss/Bleeding
- Pneumothorax
- Hemorrhage/Blood Loss/Bleeding
- Pneumothorax
Narrative
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
THE CUSTOMER REPORTED "THE PATIENT IS EXPERIENCING BLEEDING AND PNEUMOTHORAX."
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.