MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL OVERGUIDE 5/15ML CH14; SILICONE FOLEY CATHETER

Model Number	AA64141002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/13/2018
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 this lot, 6237496.Checking the quality databases revealed no anomaly in connection with the described defect.On (b)(6) we received 1 used sample and decontaminated it with anioxyde 1000 - after inflate the balloon we did not see any anomaly.The balloon burst issue is known and monitored on a monthly basis.No other corrective action will be implemented as the specific trend for balloon issue and this product family is considered acceptable.
Event or Problem Description
According to the available information, water leakage observed.Dr.Confirmed balloon burst, no residue or particle remains in patient's bladder, no clinical consequences reported.

• Brand Name: FOLYSIL OVERGUIDE 5/15ML CH14
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8189374
• Report Number: 9610711-2018-00022
• Device Sequence Number: 2026692
• Product Code: EZL
• UDI-Device Identifier: 03600040129869
• UDI-Public: 03600040129869
• 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
• Report Date (Section B): 12/17/2018

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: AA64141002
• Device Catalogue Number: AA6414
• Device Lot Number: 6237496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/21/2018
• 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