MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW DUFO 3WAY SIL 30ML CH24; CATHETER

Model Number	AB6A241002
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 information received, customer stated that there was hair in item (b)(4).Product is being returned to sales rep.

• Brand Name: X-FLOW DUFO 3WAY SIL 30ML CH24
• Common Device Name: CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 5496110
• Report Number: 9610711-2016-00010
• Device Sequence Number: 330630
• Product Code: EZL
• UDI-Device Identifier: 03600040146033
• UDI-Public: 03600040146033
• Combination Product (Y/N): N
• PMA/510(K) Number: K013172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2016

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: Lay User/Patient
• Device Model Number: AB6A241002
• Device Catalogue Number: AB6A241002
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2016
• Initial Report FDA Received Date: 03/11/2016
• Patient Sequence Number: 1