MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW STR 3WAY 50ML SI CH22; SILICONE FOLEY CATHETER

Model Number	AB60221002
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, as the catheter is blocked, drops flow dropwise in the pouch.For several patients; same lot.One patient had a clotting but they noticed it , and immediately changed the catheter for superior ch.No clinical consequences.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint on this lot n°.Checking the quality databases revealed no recorded anomaly in connection with the described incident.We received 6 sealed pouches, each contained one 3 ways silicone catheters.We measured the flow rate of the drainage channel for each of the 6 samples and we had (a minimum of ) 98.64l/h, 100.85l/h, 100.95l/h, 101.97l/h, 102.76l/h and (a max) 103.15l/h.The specification requires a min of 90l/h.The tested samples are conform to our specification.The described incident has not been reproduced on the returned tested samples.Based on the above this complaint is not confirmed as a product defect.

• Brand Name: X-FLOW STR 3WAY 50ML SI CH22
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 6066689
• Report Number: 9610711-2016-00028
• Device Sequence Number: 2102164
• Product Code: EZL
• UDI-Device Identifier: 03600040143360
• UDI-Public: 03600040143360
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2017

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: No Information
• Device Model Number: AB60221002
• Device Catalogue Number: AB60221002
• Device Lot Number: 5147333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2016
• Supplement Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1