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

Model Number	AA61081002
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Fold, Unfold or Collapse (1254); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, in a neonatal intensive care unit, a nurse wanted to remove the urinary catheter from a new born.After deflation of the balloon, the nurse felt resistance during extraction of the last 0.5 centimeters; the catheter seemed impossible to remove.The catheter was introduced again, lubricated, then extracted with success, but with force.The catheter was tested once after removing it; the balloon correctly inflated but did not fold correctly during deflation, taking the aspect of a "ring".There was no clinical consequence for the newborn.
Additional Manufacturer Narrative
Lot number: 08136651.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
Additional Manufacturer Narrative
A review of the complaint was performed and it was determined that the catheter was inflated with more liquid than was indicated by the valve.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15156306
• Report Number: 9610711-2022-00055
• Device Sequence Number: 5183791
• Product Code: EZL
• UDI-Device Identifier: 03600040126974
• UDI-Public: 03600040126974
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: AA61081002
• Device Catalogue Number: AA6108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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