MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL SILICONE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number HA6118

Device Problems Nonstandard Device (1420); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The other catheter mentioned in b5 was reported under mfr# 9610711-2023-00259.

Event Description

According to the available information the balloon has a volume of 10ml instead of 15ml; therefore, the balloon migrated and became stuck in the urethra.This occurred twice in a row on the same patient with different catheters.

Event Description

According to the available information the balloon has a volume of 10ml instead of 15ml; therefore, the balloon migrated and became stuck in the urethra.This occurred twice in a row on the same patient with different catheters.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we didn¿t find other complaints regarding the lot number (b)(6).In (b)(6) one sealed sample was received.A silicone catheter was packaged on a retail box with the corresponding labelling.No issue was observed about this sample received.Labelling of the retail box corresponding to the labelling on the primary packaging and to the sample inside.Lot number on the valve although corresponding to the documentary investigation.No issue or defect was observed, it was noted that retail box was opened before received.However, there is an error in the catalog for the reference (b)(4), as it is mention that the volume of the balloon is 15 ml instead of 10 ml.Following this complaint documents for healthcare professionals has been corrected to avoid this kind of issue in the future.A similar case study was performed based on same item number ha6118, same defect catheter migration over last four years: no similar case was found.

• Brand Name: FOLYSIL SILICONE CATHETER
• Type of Device: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18283586
• MDR Text Key: 329950060
• Report Number: 9610711-2023-00260
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040242230
• UDI-Public: 3600040242230
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: HA6118
• Device Lot Number: 8996648_HA61181002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1