MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL OVERGUIDE 5/15ML CH16; FOLEY CATHETER

Model Number	AA64161002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, catheter fell off within 2 weeks indwelling.Balloon burst.No clinical consequence for the patient.New folysil catheter was opened and used alternatively.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned device.After receiving this complaint, we searched for other complaint and we didn't find other complaint on this lot number.On 30 july, we received a used sample with an orange valve printed "16-15ml-04396880".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 has an average during the last 12 month which is considered acceptable as per the threshold.

• Brand Name: FOLYSIL OVERGUIDE 5/15ML CH16
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8843081
• Report Number: 9610711-2019-00028
• Device Sequence Number: 318999
• Product Code: EZL
• UDI-Device Identifier: 03600040129975
• UDI-Public: 03600040129975
• 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): 08/29/2019

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: AA64161002
• Device Catalogue Number: AA6416
• Device Lot Number: 4396880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/29/2019
• 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