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

Model Number AA61061002

Device Problem Blocked Connection (2888)

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

Event Date 07/23/2021

Event Type  malfunction  

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 aa61061002 lot number 7616917 for (b)(4) 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 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
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer (Section G): COLOPLAST MANUFACTURING FRANCE; 9 rue edmond rostand; lieu dit le pontet; sarlat la caneda 24206 ; FR 24206
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12365836
• MDR Text Key: 269589328
• Report Number: 3011307048-2021-00001
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040126844
• UDI-Public: 03600040126844
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AA61061002
• Device Catalogue Number: AA6106
• Device Lot Number: NOT IN LIST
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1