MAUDE Adverse Event Report: COLOPLAST A/S SILIC FOLEY CATH 5/15ML /5; SILICONE CATHETER

Model Number	AA61181002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/22/2019
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.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.No other corrective action will be implemented as the specific trend for balloon burst of this product family is considered acceptable as per the threshold.
Event or Problem Description
According to the available information, the balloon burst, and catheter came out from patient.Risk of infection and rest of balloon in the bladder.

• Brand Name: SILIC FOLEY CATH 5/15ML /5
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8699427
• Report Number: 9610711-2019-00023
• Device Sequence Number: 2473014
• Product Code: EZL
• UDI-Device Identifier: 03600040127605
• UDI-Public: 03600040127605
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/13/2019

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: AA61181002
• Device Catalogue Number: AA6118
• Device Lot Number: 6338360
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other