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

Catalog Number AA7114

Device Problem No Flow (2991)

Patient Problems Urinary Retention (2119); Discomfort (2330)

Event Date 01/09/2024

Event Type  malfunction  

Event Description

According to the available information the patient had a full bladder and wouldn't come out until the patient started to walk.

Manufacturer Narrative

The review of the complaint history database, revealed no trends for the lot number 9485199.A similar case study based on same item number (b)(4), same defect "tip broken" over last four year, no similar case was found in january, one used sample was received.We note that the tip was missing.Tip was removed from the bladder by cytoscopy checking the quality database revealed one change control cc (b)(4) "packaging - addition of longitunal precuts" opened on september 2013 and closed on january 2014 which can be possibly related to this issue.In addition, we have already had similar complaints received on the similar issue, root cause identified at that time was that customers used the transversal pre-cuts available on the inner pouch and pinched the distal end of the catheters during opening of the packaging.Consequently, the distal end of the catheters broke before use or are damaged.Since implantation of change control (b)(4), it is strongly recommended to use longitudinal precuts.Transversal precut is not recommended and should be used with great caution.

Event Description

According to the available information the patient had a full bladder and wouldn't come out until the patient started to walk.

• Brand Name: FOLYSIL SILICONE CATHETER - LONG-TERM
• 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: 18651448
• MDR Text Key: 334671324
• Report Number: 9610711-2024-00030
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/06/2024

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: AA7114
• Device Lot Number: 9485199_AA71141002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2024
• Date Device Manufactured: 11/23/2023
• 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