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

Catalog Number	AA6310
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem 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upon checking the foley balloon it was difficult to inflate and the water inserted into the balloon could not be withdrawn.Catheter was not used.
Additional 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.
Additional Manufacturer Narrative
Unfortunately, no sample was received from the customer, and we cannot go further than the documentary investigation which reveals one non-conformity recorded during production.Checking the quality databases revealed a corrective and preventive action possibly in relation with the described issue.The trending for balloon bursting is specifically monitored.A similar case study based on item number aa6310 and defect balloon over the last four years: two similar cases were found.A risk management file evaluation was performed, and concluded that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.

• 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: 18809353
• Report Number: 9610711-2024-00050
• Device Sequence Number: 15266096
• Product Code: EZL
• UDI-Device Identifier: 03600040128381
• UDI-Public: 3600040128381
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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: AA6310
• Device Lot Number: 8559622_AA63101002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2022
• 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