MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL OVERGUIDE 5/15ML CH18; SILICONE FOLEY CATHETER

Model Number	AA64181002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, when refilling the balloon, the balloon bursts.No harm to user.
Additional Manufacturer Narrative
This follow-up mdr is created to document the conclusion of the evaluation.After receiving this complaint, we searched for other complaint and we found one other complaint on this lot.Checking the quality databases revealed no anomaly in connection with the described defect.On february 11 we received 15 used samples and decontaminated them with anioxyde 1000 we tested, inflated the samples and according the procedure.The samples were put in a simulation bath from february 12th until february 26th the result of the test shows no anomaly.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.During our inflation test, we found a leakage of the red valve and the piston detached.Re-resensitizing the operators with a reinforced control was implemented.

• Brand Name: FOLYSIL OVERGUIDE 5/15ML CH18
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8371537
• Report Number: 9610711-2019-00009
• Device Sequence Number: 1587795
• Product Code: EZL
• UDI-Device Identifier: 03600040130087
• UDI-Public: 03600040130087
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/11/2019

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: AA64181002
• Device Catalogue Number: AA6418
• Device Lot Number: 6434629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1