MAUDE Adverse Event Report: TIDI PRODUCTS LLC R15/BAG, DRAIN; TABLE, CYSTOMETRIC, ELECTRIC

Model Number	25217
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Reporting rejected product due to adapters not fitting properly.Too loose.
Additional Manufacturer Narrative
H3: the device was returned for evaluation.Visual inspection and measurement confirmed that the sterile drain bag contained a male adapter that was out of tolerance, which could lead to fitment issues.No other anomalies were noted on the unit.The device history record (dhr) was reviewed and did not reveal any abnormalities in the manufacturing process.At this time, this appears to be an isolated incident, as no similar complaints have been reported for this product.As the root cause could not be determined through the quality assurance investigation, the issue has been escalated for further evaluation by a subject matter expert (sme).Manufacturer reference file: (b)(4).

• Brand Name: R15/BAG, DRAIN
• Common Device Name: TABLE, CYSTOMETRIC, ELECTRIC
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 23639391
• Report Number: 2182318-2025-00103
• Device Sequence Number: 15731297
• Product Code: MMZ
• UDI-Device Identifier: 00618125155682
• UDI-Public: 00618125155682
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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
• Device Model Number: 25217
• Device Catalogue Number: 25217
• Device Lot Number: 70524763
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown