inforMED
InjuryFCE

BAG,ENEMA,W/SLIDE CLAMP,BOXED

Received Sep 4, 2024 · Event occurred May 4, 2024

Report 1417592-2024-00837 · MDR key 20136351

Device

Generic name

Bag,enema,w/slide Clamp,boxed

Catalog number

DYND70100

Product problems

  • Appropriate Device Problem Term/Code Not Available
  • Appropriate Device Problem Term/Code Not Available

Patient

74 YR · Male

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY ON (B)(6) 2024, "RN ADMINISTERED A TAP WATER ENEMA USING MEDLINE CLEANSING ENEMA SET DYND70100. THE RN FILLED THE ENEMA BAG WITH TAP WATER, OPENED THE PLASTIC SLIDE AND CLEARED THE TUBING OF AIR, INSERTED THE ENEMA TUBING WITH THE BLUE CAP ON IT INTO THE PATIENT'S RECTUM, REOPENED THE PLASTIC SLIDE AND ADMINISTERED THE ENEMA FLUID INTO THE PATIENT'S RECTUM. REPORTED RETAINED CAP TO THE PHYSICIAN. X-RAY WAS DONE TO IDENTIFY CAP BUT UNABLE TO SEE CAP IN RECTUM. NURSING OBSERVED PATIENT'S STOOLS FOR 3 DAYS UNTIL SUCCESSFUL PASSAGE OF THE ENEMA TUBING CAP. NO PATIENT ISSUES RELATED TO THIS INCIDENT HAVE BEEN REPORTED" IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, 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 FACILITY ON (B)(6) 2024, "RN ADMINISTERED A TAP WATER ENEMA USING MEDLINE CLEANSING ENEMA SET DYND70100. THE RN FILLED THE ENEMA BAG WITH TAP WATER, OPENED THE PLASTIC SLIDE AND CLEARED THE TUBING OF AIR, INSERTED THE ENEMA TUBING WITH THE BLUE CAP ON IT INTO THE PATIENT'S RECTUM, REOPENED THE PLASTIC SLIDE AND ADMINISTERED THE ENEMA FLUID INTO THE PATIENT'S RECTUM."