MAUDE Adverse Event Report: COLOPLAST A/S PERCUTANEOUS NEPHROSTOMY DILATOR; ENDOSCOPIC-ACCESS DILATOR, SINGLE-USE

Catalog Number	RBA008
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.B3: estimated date.
Event or Problem Description
According to the available information, one of the dilators does not have the notation ¿fr¿ on it.This was discovered internally prior to shipment to customers.The box has been discarded.
Event or Problem Description
According to the available information, one of the dilators does not have the notation ¿fr¿ on it.This was discovered internally prior to shipment to customers.The box has been discarded.
Additional Manufacturer Narrative
The review of the complaint history database, revealed no trends for the lot number 10137108.Documentary investigation revealed no anomaly registered during production.In february, we received one retail box, with 5 sealed samples.In one of them, dilator was not marked.This defect was well observed on only one device.The quality team has informed the operators about this issue.According to the informations known quality database was checked and revealed no anomaly in relation to the describe defect.

• Brand Name: PERCUTANEOUS NEPHROSTOMY DILATOR
• Common Device Name: ENDOSCOPIC-ACCESS DILATOR, SINGLE-USE
• 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: 21415612
• Report Number: 9610711-2025-00031
• Device Sequence Number: 21143655
• Product Code: EZN
• UDI-Device Identifier: 03600040953679
• UDI-Public: 3600040953679
• Combination Product (Y/N): N
• PMA/510(K) Number: K170531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: Other
• Device Catalogue Number: RBA008
• Device Lot Number: 10137108_RBA0084002
• Is the Reporter a Health Professional?: No
• 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: 02/19/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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