SAFE-T-CENTESIS
Received Jun 10, 2026 · Event occurred May 13, 2026
Report 1423507-2026-00082 · MDR key 25453145
Device
Product problems
- Difficult to Remove
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING TROCAR INSERTION, THE TROCAR DETACHED FROM THE HOLDER AND NEARLY SLIPPED INTO THE BODY CAVITY WITH THE TUBE. DURING FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED FOR ASCITES ASSOCIATED WITH A RETROPERITONEAL PARAGANGLIOMA. THE DRAINAGE PUNCTURE AND SYSTEM PLACEMENT WERE BOTH IN THE LOWER LEFT ABDOMEN. WHEN THE DRAINAGE TUBE/GUIDE WIRE WAS WITHDRAWN, THE GUIDE WIRE MOVED AS EXPECTED; HOWEVER, THE HOLLOW NEEDLE REMAINED WITHIN THE TUBE. A NEW SITE WAS SUBSEQUENTLY USED TO INSERT THE DRAIN LINE. NO BLOODY ASCITES FLUID WAS OBSERVED, AND THE PATIENT REMAINED ASYMPTOMATIC; THEREFORE, NO INJURY WAS REPORTED. THE PATIENT IS IN PALLIATIVE CARE, CONDITION DETERIORATING, THOUGH THIS WAS NOT CAUSED BY THE EXAMINATION.
Additional Manufacturer Narrative
H11: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. PHOTOS WERE PROVIDED; PHOTO REVIEW IS UNDERWAY. THE DEVICE IS PENDING RETURN. 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.