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

Model Number AA61081002

Device Problems Hole In Material (1293); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

According to the available information, catheter has been inserted to a pediatric patient in emergency unit because of urinary retention.Patient was then transferred to pediatric ward, where the catheter had come out by itself the next morning.Catheter's balloon was tested and it was found out that the fluid doesn't stay inside the balloon, and that there was a hole on the catheter's balloon fluid canal.

• Brand Name: PED FOLYSIL CATH 3ML CH08/5
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING FRANCE; coloplast manufacturing france; 9 avenue edmond rostand; sarlat la caneda, 24206 ; FR 24206
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5555815
• MDR Text Key: 42760008
• Report Number: 9610711-2016-00012
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040126974
• UDI-Public: 03600040126974
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AA61081002
• Device Catalogue Number: AA61081002
• Device Lot Number: 12071826
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention