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

Catalog Number AA6114

Device Problem No Flow (2991)

Patient Problems Internal Organ Perforation (1987); Urinary Retention (2119)

Event Date 01/05/2024

Event Type  Injury  

Event Description

According to the available information at the incision, bladder wound due to the presence of a bladder globe.Bladder wound needed to be sutured.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9460161.A similar case study was performed based on same item number and defect [product drainage] issue over last four year: three similar cases were found.We received one used sample.After disinfection, sample was observed, no defect was noted through the visual examination, no traumatic part or barbs was observed on the catheter.Inflation / deflation test was performed and no issue was observed at this test.Drainage functionality was also performed and no defect was observed.Examination of the sample cannot permit to determine the root cause about the defect explained in the complaint.Based on performed investigation, checking the quality database revealed no anomaly in relation to the described defect.A risk management framework evaluation was performed and concluded that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.

Event Description

According to additional available information, the balloon was tested before insertion (by inflation/deflation) and showed no asymmetry.

• 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: 18681471
• MDR Text Key: 335047395
• Report Number: 9610711-2024-00032
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AA6114
• Device Lot Number: 9460161_AA61141002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2023
• 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
• Patient Outcome(s): Other