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

Catalog Number AA6112

Device Problem Complete Blockage (1094)

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

Event Date 10/06/2023

Event Type  malfunction  

Event Description

According to the available information, after fitting the bladder catheter, it was impossible to instill the chemotherapy (gemcitabine 1g/50ml, 6th instillation).The bladder catheter was removed, and a permeability test carried out; the catheter was not permeable.A new catheter from the same batch was inserted after permeability had been checked.

Manufacturer Narrative

After receiving this complaint, we searched for other complaint and we didn¿t find other complaint on the lot number 8931413.In november, we received one used sample.After desinfection, drainage was tested and conformed, inflation/deflation functionality was tested and conformed.No issue was observed about this catheter, so no root cause can be identified.A similar case study based on same item number (b)(4) same defect permeability issue over last four year, no similar case was found.Checking the quality database revealed no anomaly in relation with the described product.

Event Description

According to the available information, after fitting the bladder catheter, it was impossible to instill the chemotherapy (gemcitabine 1g/50ml, 6th instillation).The bladder catheter was removed, and a permeability test carried out; the catheter was not permeable.A new catheter from the same batch was inserted after permeability had been checked.

• 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: 18110494
• MDR Text Key: 327905725
• Report Number: 9610711-2023-00241
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127230
• UDI-Public: 3600040127230
• 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: 05/17/2024

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: AA6112
• Device Lot Number: 8931413_AA61121002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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