MAUDE Adverse Event Report: TIDI PRODUCTS LLC R15/COVER, C-ARM X-RAY TUBE, 3; DRAPE, SURGICAL, EXEMPT

Model Number	20770
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned; however, images provided by the customer indicate that the pouch was improperly sealed, with no evidence of a complete or broken seal.A physical evaluation could not be performed.No additional product issues were reported.Manufacturing records review is planned, but not yet started.The quality team is actively working to complete the investigation, and outreach has been made to the customer to determine if the defective product is still available for return and evaluation.There have been no similar complaints reported for this sku in the past five years.The current complaint rate is (b)(4).At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.
Event or Problem Description
The side opposite the rubber was not properly sealed.

• Brand Name: R15/COVER, C-ARM X-RAY TUBE, 3
• 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: 22486521
• Report Number: 2182318-2025-00069
• Device Sequence Number: 8041084
• Product Code: PUI
• UDI-Device Identifier: 00618125168026
• UDI-Public: 00618125168026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/10/2025

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: 20770
• Device Catalogue Number: 20770
• Device Lot Number: 68278216
• 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: 06/10/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2025
• 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
• Patient Sex: Unknown