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

Catalog Number	AA6112
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9610711-2023-00241
• Device Sequence Number: 7717882
• Product Code: EZL
• UDI-Device Identifier: 03600040127230
• UDI-Public: 3600040127230
• Combination Product (Y/N): N
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: AA6112
• Device Lot Number: 8931413_AA61121002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown