MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 2912701400

Device Problem Deflation Problem (1149)

Patient Problem Pain (1994)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

This case involves use of the peristeen transanal irrigation system on a child.After use of the device on the child the balloon on the catheter failed to deflate.The blue tube was disconnected from the dial; however, the balloon remained inflated.In order to deflate the balloon successfully the clear part of the blue tube had to be physically cut by the user.The child was not injured; however, it was stated that the child was in great pain due to the inability to evacuate the water and stool prior to the balloon deflation.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

• Brand Name: PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11204398
• MDR Text Key: 228917836
• Report Number: 3006606901-2021-00001
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 05708932514934
• UDI-Public: 05708932514934
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/08/2022
• Device Model Number: 2912701400
• Device Catalogue Number: 29127
• Device Lot Number: 7520503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 YR