MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW COUV 3WAY 50ML SI CH20; PROSTATECTOMY CATHETER

Model Number	AB61201002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint on the lot n° 7115558.On january 28, we received 2 opened samples- the samples were placed in a simulation bath from january 28 until february 03- and before, inflated the balloons with osmosis water.At the exit of the test the balloons were still inflated.The balloon burst issue is known and monitored on a monthly basis, a possible root cause is a weakness area in the silicone material of the balloon.
Event or Problem Description
According to the available information, the balloon burst when cuffing.

• Brand Name: X-FLOW COUV 3WAY 50ML SI CH20
• Common Device Name: PROSTATECTOMY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9713885
• Report Number: 9610711-2020-00005
• Device Sequence Number: 16979567
• Product Code: EZL
• UDI-Device Identifier: 03600040143711
• UDI-Public: 03600040143711
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K013172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/09/2024
• Device Model Number: AB61201002
• Device Catalogue Number: AB6120
• Device Lot Number: 7115558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1