MAUDE Adverse Event Report: COLOPLAST A/S URETERIC INTERVENTIONAL CATHETER; URETERAL CATHETER

Catalog Number	ACP205
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the benefit of analyzing the device, coloplast cannot comment on the condition of the device.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.B3: estimated date.
Event or Problem Description
According to the available information, the package was unable to be opened without compromising sterility.The physician opened a new one to resolve the issue.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 9721110.In (b)(6) 2025, we received one used sample, the packaging was teared.It seemed that an issue occured during the packaging opening.This packaging was done at our tatabanya's site which investigate about this issue and conclude, no non-conformity in our production processes or in our work instructions were mentioned during this investigation.No root cause can be identified.Checking quality database revealed no anomaly in connection with the described problem.A similar case study was performed based on item acpxxx; defect: difficult to open the packaging from january 2021 to january 2025; 3 similar cases were found (b)(4).The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art level.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.It is concluded that the risks identified are still acceptable and considered as safe.
Event or Problem Description
According to the available information, the package was unable to be opened without compromising sterility.The physician opened a new one to resolve the issue.

• Brand Name: URETERIC INTERVENTIONAL CATHETER
• Common Device Name: URETERAL CATHETER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21126429
• Report Number: 9610711-2025-00012
• Device Sequence Number: 7677441
• Product Code: EYB
• UDI-Device Identifier: 03600040323588
• UDI-Public: 3600040323588
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K171043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: ACP205
• Device Lot Number: 9721110_ACP2051400
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• 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