SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 8FR X 25CM
Received Feb 14, 2023 · Event occurred Feb 6, 2023
Report 0001625425-2023-00967 · MDR key 16372209
Device
Product problems
- Dull, Blunt
- Dull, Blunt
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THERE IS DIFFICULTY WHEN INSERTING THE DEVICE INTO THE PATIENT, IT IS NOT POSSIBLE TO PERFORM DIRECT PUNCTURE AND WITH THE NEED TO USE OTHER DEVICES TO INSERT THE CATHETER. IT HAS HAPPENED SEVERAL TIMES, REPORTS THE INSTITUTION.
Additional Manufacturer Narrative
ACCORDING TO THE PRODUCT EXPERIENCE REPORT, THERE WAS NO SAMPLE TO BE RETURNED. ADDITIONALLY, NO PHOTOGRAPHIC OR VISUAL EVIDENCE OF ANY KIND WAS PROVIDED WHICH WOULD HAVE ALLOWED FOR THE ALLEGATION TO BE REVIEWED. WITHOUT SUCH EVIDENCE, THIS COMPLAINT COULD NOT BE CONFIRMED AND DETERMINING A DEFINITE ROOT CAUSE AND CORRECTIVE ACTION IS NOT POSSIBLE. IF THE SAMPLE IS RETURNED AT A FUTURE DATE, A FOLLOW-UP REPORT WILL BE SUBMITTED.