MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; SILICONE CATHETER

Model Number	AA64181002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we could not search for other complaint as the lot number is not available.With the lot number of the red valve 6619792, we found the product intermediate is aa641879 lot number 6619792 and entered in the manufacture in the product reference aa64181002 lot number 6863149 for (b)(4) pieces was manufactured in may 2019.The expiry date is may 2024.On may 12th, we didn't receive the announced sample, but the silicone balloon issue is known.The samples are delayed due to the covid-19 situation.The expected sample has not yet been received.Upon receipt, it will be examined, the complaint will be reopened.The balloon burst issue is known and monitored on a monthly basis.Possible root cause is a weakness area in the silicone material of the balloon.
Event or Problem Description
According to the available information, the catheter fell off after 1 day indwelling.Balloon burst was found.The lot number of the red valve was provided, 6619792.
Additional Manufacturer Narrative
This follow-up is created to document the device return.The final answer remains unchanged.

• Brand Name: FOLYSIL CATHETER
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1-3; humlebaek, 3050 ; DA 3050
• MDR Report Key: 10062379
• Report Number: 9610711-2020-00014
• Device Sequence Number: 17037536
• Product Code: EZL
• UDI-Device Identifier: 03600040130087
• UDI-Public: 03600040130087
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013174
• 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,Followup
• Report Date (Section B): 06/09/2020

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: Health Professional
• Device Model Number: AA64181002
• Device Catalogue Number: AA6418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1