MAUDE Adverse Event Report: WELLSPECT HEALTHCARE NAVINA SMART SYSTEM; NAVINA TUBING

Model Number	69011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A caregiver (the patient's mother) reported observing small areas of black mold growth inside the tubing of the navina smart transanal irrigation system.The caregiver stated that the tubing is routinely left out to air dry after each use.However, due to high humidity in their local environment, mold growth was observed.A photo was provided to support the claim.No harm or injury was reported in connection with this complaint.
Additional Manufacturer Narrative
The affected product's lot number was not provided, and the used device will not be returned for evaluation.As a result, a batch-specific investigation could not be conducted.A review of general batch release procedures confirmed that routine inspections are performed, and no signs of contamination or mold have been observed in released products.The caregiver was provided with a replacement tubing and additional cleaning instructions in accordance with the product's instructions for use (ifu).Based on the available information, the reported issue appears to be related to environmental conditions during post-use handling rather than a device malfunction.The product functioned as intended, and no systemic quality issues have been identified.

• Brand Name: NAVINA SMART SYSTEM
• Common Device Name: NAVINA TUBING
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer (Section G): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer Contact: emad ramzi ; aminogatan 1; p.o. box 14; mölndal, se-43 121 mölndal ; SW
• MDR Report Key: 22712391
• Report Number: 3009632672-2025-00024
• Device Sequence Number: 18548679
• Product Code: KNT
• UDI-Device Identifier: 07333387027999
• UDI-Public: 07333387027999
• Combination Product (Y/N): N
• PMA/510(K) Number: K190977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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: Lay User/Patient
• Device Model Number: 69011
• Device Catalogue Number: 6901140
• Device Lot Number: UNKWON
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White