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

Catalog Number AA6120

Device Problem Failure to Deflate (4060)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

According to the available information balloon was unable to be emptied and there was a leakage from the balloon.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we found one other complaint regarding the lot number 8408112 on a leakage issue (b)(4).The product reference aa61201002 lot number 8408112 was manufactured in january 2022 for (b)(4) pieces.The expiry date is january 2027.The product reference aa61201002 lot number 8408112 was manufactured with an intermediate product aa612080 lot number 8115468.This intermediate was made with balloon component reference (b)(4) lot number 7780201.This product was made by our subcontractor which was informed about this issue.Checking the quality databases revealed one corrective and preventive action: monitoring capa-000152: "balloon issues on folysil and silicone prostatic catheters".The trending for inflation/deflation issue on folysil catheters is specifically monitored.

• 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; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18802934
• MDR Text Key: 336509760
• Report Number: 9610711-2024-00047
• Device Sequence Number: 1
• Product Code: EZL
• 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
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AA6120
• Device Lot Number: 8408112_AA61201002
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 01/27/2022
• 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