MAUDE Adverse Event Report: COLOPLAST A/S PED FOLYSIL CATH 3ML CH10/5; SILICONE FOLEY CATHETER

Model Number	AA61101002
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/06/2017
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.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to the available information, patient noticed a wire sticking out of the tip of the foley catheter before use.They did not use the item.
Additional Manufacturer Narrative
This follow-up mdr is created to document the evaluation of the returned product: the mandrel exits through the eye.Checking the quality databases revealed no anomaly in connection with the described defect.We sent the returned samples to our site and asked them to make the necessary analyzes and investigations in order to be able to respond to this complaint.The results of the analysis indicate there are 2 possible hypotheses: the mandrel comes out of the piece following transport.The mandrel exits the piece following conditioning.On july 28, 2017, implementation of the corrective actions: reinforced control over 3 successive expeditions.Resensitization of operators for packaging by the manager based on all this information, the complaint is confirmed as a product defect.

• Brand Name: PED FOLYSIL CATH 3ML CH10/5
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 6457885
• Report Number: 9610711-2017-00013
• Device Sequence Number: 10881788
• Product Code: EZL
• UDI-Device Identifier: 03600040127100
• UDI-Public: 03600040127100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: AA61101002
• Device Catalogue Number: AA61101002
• Device Lot Number: 5056429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1