MAUDE Adverse Event Report: MEDLINE; CLEANSING ENEMA SET, BOXED

Catalog Number DYND70100

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/11/2018

Event Type  malfunction  

Event Description

While admitted to the facility, a patient experienced constipation.A soap suds enema is ordered.A boxed enema set is utilized for setup and use.Later in the day the patient is discharged to home.The patient's family called the facility (much later) to share that while at home and providing peri-care to the former patient, a blue object is noted to be protruding from her anus.The blue item is pulled out by family and they notified the facility with photos of the item.The item is thought to be (by family) the blue tip protector, which covers the pre-lubricated tubing.Manufacturer notified by patient's family and facility.No response.Family express wishes to make improvements to the product to prevent such an issue from happening in the future.The device and photos are available.

• Type of Device: CLEANSING ENEMA SET, BOXED
• Manufacturer (Section D): MEDLINE; 1204 townline rd; 1 medline place; mundelein IL 60060
• MDR Report Key: 8073077
• MDR Text Key: 127231327
• Report Number: 8073077
• Device Sequence Number: 1
• Product Code: FCE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND70100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31755 DA