MEDLINE
Received May 19, 2026 · Event occurred Mar 1, 2026
Report 1417592-2026-01483 · MDR key 25219432
Device
Generic name
Bag,enema,w/slide Clamp,polybag
Manufacturer
Medline Industries, LpCatalog number
DYND70102
Product problems
- Use of Device Problem
Patient
74 YR · Male
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY, IN (B)(6) 2026, DURING A SOAP SUDS ENEMA, THE RN DID NOT REMOVE THE SOAP ENEMA CAP PRIOR TO INSERTING ENEMA INTO THE PATIENT'S RECTUM WHICH RESULTED IN A RETAINED FOREIGN BODY REQUIRING A PROCEDURE AND SEDATION TO HAVE IT REMOVED. NO ADDITIONAL INFORMATION AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.
Description of Event or Problem
ACCORDING TO THE FACILITY, IN (B)(6) 2026, DURING A SOAP SUDS ENEMA, THE RN DID NOT REMOVE THE SOAP ENEMA CAP PRIOR TO INSERTING ENEMA INTO THE PATIENT'S RECTUM WHICH RESULTED IN A RETAINED FOREIGN BODY REQUIRING A PROCEDURE AND SEDATION TO HAVE IT REMOVED.