MAUDE Adverse Event Report: WELLSPECT HEALTHCARE NAVINA SYSTEM; NAVINA CONSUMABLE SET SMALL

Model Number	69004
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A foreign incident occurred outside the united states and was limited to a single country.A customer ordered a navina small rectal catheter intended for transanal irrigation but received a navina regular rectal catheter instead.The discrepancy was identified prior to use; the catheter was not used and was returned to the manufacturer.
Additional Manufacturer Narrative
A foreign event involving a mispackaged device.A customer ordered a navina small rectal catheter intended for transanal irrigation but received a navina regular rectal catheter instead.The discrepancy was detected before use.The catheter was not used and was returned to the manufacturer.The manufacturer conducted an investigation and confirmed that the incorrect catheter size had been included in the kit during assembly for one specific batch.All remaining kits from the same lot were quarantined before distribution, and the kits previously delivered to the customer have been returned.No harm occurred, and no patient exposure took place.The root cause was identified as an isolated component mix up during manual kitting.A capa has been initiated to strengthen component segregation, review assembly controls, and prevent recurrence.

• Brand Name: NAVINA SYSTEM
• Common Device Name: NAVINA CONSUMABLE SET SMALL
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; molndal, SE-43 121; SW SE-43 121
• Manufacturer (Section G): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; molndal, SE-43 121; SW SE-43 121
• Manufacturer Contact: emad ramzi ; aminogatan 1; p.o.box 14; molndal, SE-43-121 ; SW SE-43121
• MDR Report Key: 24578523
• Report Number: 3009632672-2026-00008
• Device Sequence Number: 9233181
• Product Code: KNT
• UDI-Device Identifier: 07333387025506
• UDI-Public: 07333387025506
• 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: Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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: 69004
• Device Catalogue Number: 6900480
• Device Lot Number: 675627
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown