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

Model Number	AA61101002
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Examination of the returned product revealed the stylet was out of the catheter near the eyelets.
Event or Problem Description
According to the available information, the children's catheter caused an unspecified injury.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we didn't find another complaint on the lot number 8255369.The product reference aa611021002 lot number 8255369 for 1170 pieces, has been packaged in october 2021.The expire date is october 2026.The product reference ac42641002 lot number 8595061 was made by an intermediate product reference aa611080 lot number 7855605, made by our tunisian subcontractor.Checking the quality databases revealed no anomaly in connection with the described defect.On 27th july, we informed to our tunisian subcontrator of this complaint.On 29th july, we received one used sample.After decontamination of the sample, we found that the stylet is out of the catheter by the eyes.After discussion with the appropriate persons to better understand the course of the incident, we concluded that the catheter was not placed by a healthcare professional.Our clinical assessment concluded : urethral catheterization is a standard surgical technique and pediatric folysil catheters should be placed by trained healthcare professionals.The incident traumatic pediatric catheter due to a misuse in this case as the catheter was not placed by a healthcare professional (non-respect of warnings in the ifu), associated with clinical consequences such as urethral injury, pain, bleeding represents a clinical risk rated severity parameter level 3 referring to our clinical risk management procedure (b)(4).The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art.Based on this, we can conclude 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.

• Brand Name: FOLYSIL CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15193216
• Report Number: 9610711-2022-00056
• Device Sequence Number: 6013539
• Product Code: EZL
• UDI-Device Identifier: 03600040127100
• UDI-Public: 03600040127100
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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 Model Number: AA61101002
• Device Catalogue Number: AA6110
• Device Lot Number: 8255369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• 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