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

Catalog Number	AA6114
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information the patient removed her catheter and upon inspection of the catheter, the balloon was not found and believed to have remained in the patient.
Event or Problem Description
According to additional available information, the indication for catheterization was severe dementia and malnutrition.The balloon was tested prior to use with no anomaly and optilube lubricant was used on catheter.The volume of inflation fluid was 20ml and sterile water was used.No symptoms developed within the 24 hours following the reported issue.
Additional Manufacturer Narrative
After receiving this complaint, we were unable to investigate further complaints and conduct documentary investigations to look for any anomaly recorded during production as neither the lot number nor the sample are available.Thus, no investigation can be made for this complaint.Quality database was checked with elements known, no anomaly in relation to the described defect was registered.Through information obtained during exchanges [with the reporter] it was noted that the balloon was inflated at 20ml.Recommendation for this reference [device] is to use 15ml of liquid as over-inflation can lead to balloon bursting.Similar case study was performed based on same item number and same defect [drainage issue] over last four years: no similar case was found.However, this complaint will be used for trend analysis.

• 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: 18689313
• Report Number: 9610711-2024-00033
• Device Sequence Number: 12361253
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 3600040127360
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AA6114
• 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: 02/12/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown