MAUDE Adverse Event Report: COLOPLAST A/S SILICONE FOLEY 30CC ST CH18 /5; SILICONE FOLEY CATHETER

Model Number	AA6C181002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint on this lot n°5878237.We received a used sample with an red valve printed "(b)(4)".At visual examination, we can see that the balloon is burst but no piece is missing.The balloon burst issue is known and monitored on a monthly basis.Unfortunately we don't know the root cause.Based on the above , this complaint is confirmed as a product defect.No other corrective action will be implemented as the specific trend for balloon burst and this product family is considered acceptable as per the threshold.
Event or Problem Description
According to the available information, the catheter fell off due to balloon burst.The physician replaced the device with a new catheter immediately, no clinical consequences reported.No residue or particle remains in patient's bladder.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation codes.

• Brand Name: SILICONE FOLEY 30CC ST CH18 /5
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8174798
• Report Number: 9610711-2018-00021
• Device Sequence Number: 2178514
• Product Code: EZL
• UDI-Device Identifier: 03600040131992
• UDI-Public: 03600040131992
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: AA6C181002
• Device Catalogue Number: AA6C18
• Device Lot Number: 5878237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1