MAUDE Adverse Event Report: COLOPLAST A/S RELEEN INLINE URINARY INDWELLING DRAINAGE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number 28766

Device Problem Material Rupture (1546)

Patient Problem Urinary Tract Infection (2120)

Event Type  malfunction  

Event Description

According to the available information the consumer has been receiving nursing support for supra pubic catheter changes.Unfortunately, the catheter balloon frequently splits causing the catheter to fall out.This causes a lot of stress as immediate medical attention is required when this happens, and the patient experiences urinary tract infections.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we didn¿t find any on lot number.Checking the quality database showed no anomaly in relation with the described defect.We were unable to know the exact defective cause because we did not receive the actual defective sample.Risk management framework evaluation was performed.Risks are adequately controlled and reduced as far as possible.It is concluded that the risks identified are still acceptable and considered as safe.B3: estimated date.

• Brand Name: RELEEN INLINE URINARY INDWELLING DRAINAGE 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: 18150096
• MDR Text Key: 328299040
• Report Number: 9610711-2023-00249
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 05708932906265
• UDI-Public: 5708932906265
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/16/2023

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: Lay User/Patient
• Device Catalogue Number: 28766
• Device Lot Number: 8780235_2876611800
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2023
• Date Device Manufactured: 12/13/2022
• 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