DIV18 CRITICAL CARE - MISCELLANEOUS
Received Jan 28, 2025 · Event occurred Nov 12, 2024
Report 1417592-2025-00044 · MDR key 21252156
Device
Generic name
Div18 Critical Care - Miscellaneous
Manufacturer
Medline Industries, LpCatalog number
DIV18
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
80 YR · Male
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
UPDATE TO H6: INVESTIGATION FINDINGS. UPDATE TO H6: INVESTIGATION CONCLUSIONS.
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER, AFTER AN ENEMA WAS ADMINISTERED ON (B)(6) 2024 IT WAS NOTED THAT "THE CAP OF THE ENEMA TUBING WAS NOT TAKEN OFF AND WAS INSERTED INTO THE RECTUM". THE CUSTOMER REPORTED THAT THE PATIENT REQUIRED A "SIGMOIDOSCOPY" FOR REMOVAL OF THE CAP. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. NO ADDITIONAL INFORMATION IS AVAILABLE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
ACCORDING TO THE CUSTOMER, AFTER AN ENEMA WAS ADMINISTERED ON (B)(6) 2024 IT WAS NOTED THAT "THE CAP OF THE ENEMA TUBING WAS NOT TAKEN OFF AND WAS INSERTED INTO THE RECTUM".