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

Catalog Number	AA6310
Medical Device Problem Codes	Inflation Problem (1310); 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upon checking the foley balloon it was difficult to inflate and the water inserted into the balloon could not be withdrawn.Catheter was not used and no harm to the patient.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints, and we found one other complaint on the lot n° 8559622.One used sample was received.After disinfection, functionality of the catheter was tested.Balloon was inflated with air and deflated without difficulty and no leakage was observed.Balloon was then inflated with osmosis water, inflation was more difficult than usual and deflation was hard.Hypothesis: inflation eye was too little, misplaced or obstructed.This used sample was sent to our subcontractor for investigation.Our subcontractor investigated and concluded: " an inflation test was carried out, confirming the difficulty of inflating and deflating the balloon.The cause of this defect is the presence of a semi-corking which makes it difficult to inflate and deflate the balloon.Operator awareness was ensured." checking the quality databases revealed this type of defect is closely monitored a similar case study based on item number aa6310 with 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: 18809256
• Report Number: 9610711-2024-00049
• Device Sequence Number: 7248296
• 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): Yes
• 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