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

Model Number	AA63121002
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned product found the green film opened via the transversal pre-cut.The device funnel was broken.Investigation of similar complaints determined the root cause was that customers using the transversal precuts available on the inner pouch, had pinched the distal end of the catheters while opening the packaging.Consequently, the distal end of the catheters broke before use.The packaging was improved by adding a longitudinal pre-cut on the inner peel pouch to facilitate opening and avoid such an effect.Investigation determined that while tearing the transversal precut, the user also tore the distal tip of the catheter without noticing.Therefore, the cause was determined to be misuse.
Event or Problem Description
According to the available information, the catheter tears apart when the package is opened.The catheter was not used, and no patient complications occurred.

• Brand Name: FOLYSIL CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12252317
• Report Number: 9610711-2021-00047
• Device Sequence Number: 17104320
• Product Code: EZL
• UDI-Device Identifier: 03600040128510
• UDI-Public: 03600040128510
• 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
• Report Date (Section B): 06/23/2021

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 Expiration Date: 11/19/2025
• Device Model Number: AA63121002
• Device Catalogue Number: AA6312
• Device Lot Number: 7748373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1