MAUDE Adverse Event Report: COLOPLAST A/S PED FOLYSIL CATH 3ML CH08/5; SILICONE FOLEY CATHETER

Model Number	AA61081002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find an other complaint on the lot number 6225732.Checking the quality databases revealed no anomaly in connection with the described defect.Instructions for use : recommends that prior the catheterisation it is usual practice to check that the valve and balloon are functioning properly by inflating and then deflating the balloon.Warning: pediatric catheters of diameters 06,08 and 10ch may include a stylet that facilities their insertion.Before insertion: make sure that the stylet can move in the catheter and examine the end of the catheter to ensure that the stylet is positioned perfectly inside the catheter and does not comes out of an eye.However, in this case, we think that the torn end may be due when testing the functionality or when inserting into the patient with stylet manipulation.
Event or Problem Description
According to the available information, catheter laid in patient´s diapers - balloon looks damaged.It is unclear if the tip is damaged or missing.

• Brand Name: PED FOLYSIL CATH 3ML CH08/5
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8761190
• Report Number: 9610711-2019-00025
• Device Sequence Number: 13825304
• Product Code: EZL
• UDI-Device Identifier: 03600040126974
• UDI-Public: 03600040126974
• 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
• Report Date (Section B): 07/01/2019

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: AA61081002
• Device Catalogue Number: AA6108
• Device Lot Number: 6225732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 07/03/2019
• 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