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

Catalog Number AA6310

Device Problem Failure to Deflate (4060)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

According to the available information upon checking the foley balloon it was difficult to inflate and the water inserted into the balloon could not be withdrawn.Catheter was not used.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we found another complaint on the lot n° 8559622 (b)(4).The aa63101002 lot 8559622 has been packaged with intermediate products ref (b)(4) lot 7983323 in may 2023 and the expiry date is may 2028.The aa631080 lot 7983323 has been manufactured by our tunisian site.(informed) checking the quality databases revealed no anomaly in connection with the described defect.

• 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: 18809353
• MDR Text Key: 336807510
• Report Number: 9610711-2024-00050
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2024

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: AA6310
• Device Lot Number: 8559622_AA63101002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2024
• Date Device Manufactured: 05/06/2022
• 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