MAUDE Adverse Event Report: COLOPLAST A/S MANUFACTURING FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	AA61061002
Medical Device Problem Codes	Deflation Problem (1149); Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint indicates this issue occurred 4 times, thus 4 total related complaints exist: (b)(4).One used sample was received with a green valve lot number 7456099.The balloon was inflated with 1.5ml of air and the balloon was deflated without any abnormalities.Moreover, adhesive was noted at 12cm of the funnel, measured with the rule lab300-1.However, according the ifu sh2115: "warning/precautions: if the catheter needs to be secured, the adhesive must be applied to the connector." after we received the sample, we made a tracking in our e1 system and found that the intermediate product received aa610679 lot number 7456099 was made with the product reference (b)(4) lot number 7616917 for 1106 pieces and has been manufactured in august 2020.The expiry date is august 2025.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to available information, the balloon deflated and a blockage at the deflated balloon was noted.The physician removed the device.The complaint indicates this issue occurred 4 times, thus 4 total related complaints exist: (b)(4).

• Brand Name: FOLYSIL CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• MDR Report Key: 12362829
• Report Number: 9610711-2021-00064
• Device Sequence Number: 14406012
• Product Code: EZL
• UDI-Device Identifier: 03600040126844
• UDI-Public: 03600040126844
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: No Information
• Device Model Number: AA61061002
• Device Catalogue Number: AA6106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1