MAUDE Adverse Event Report: TIDI PRODUCTS LLC BAG, CLEAR BAND, 36X30; DRAPE, SURGICAL, EXEMPT

Model Number	CFI-655
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return sample was requested, but has not yet been evaluated.Therefore, this report is based on customer provided information only.Evaluation of the customer-returned sample is pending.An image was provide by the customer and review, however it is difficult to confirm or understand the defect based on the image alone.The dhr for this lot (66444801, manufactured 1/30/2025) was reviewed and identified no nonconformances or other anomalies noted that could have contributed to the reported failure.All evaluated samples passed inspection prior to release for distribution.Historical complaint data review identified no other complaints documented for this sku in the last 3 years, and only one other complaint for this product family for an unrelated issue.This product family has a very low complaint rate of (b)(4) based on sales volume during this time.Currently, this appears to be an isolated incident.Return product samples will be evaluated to attempt to confirm the defect and determine root cause and potential corrective actions.Manufacturer reference file: (b)(4).
Event or Problem Description
Customer reported item# cfi-655 comes apart during draping or when repositioning the c-armor.

• Brand Name: BAG, CLEAR BAND, 36X30
• Common Device Name: DRAPE, SURGICAL, EXEMPT
• 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: 22751878
• Report Number: 2182318-2025-00075
• Device Sequence Number: 20982184
• Product Code: PUI
• UDI-Device Identifier: 00618125140428
• UDI-Public: 00618125140428
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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: CFI-655
• Device Catalogue Number: CFI-655
• Device Lot Number: 66444801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 08/08/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown