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

Model Number	2912701400
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11204398
• Report Number: 3006606901-2021-00001
• Device Sequence Number: 3443334
• Product Code: KNT
• UDI-Device Identifier: 05708932514934
• UDI-Public: 05708932514934
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR