MAUDE Adverse Event Report: TIDI PRODUCTS LLC DRAPE, C-ARM 6600/6800, 48X84; DRAPE, SURGICAL

Model Number	5403
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the complaint product will not be returned to manufacturer.Therefore, this report is based solely on customer provided information.The product was returned and reviewed by the distributor and confirmed tear in drape.The dhr was reviewed and found no issues noted during production.Historical complaint data review identified one other complaint for holes/tears for this sku in the last 2 years, however the complaint could not be confirmed after evaluation of return samples.With the information available the root cause could not be determined; therefore no further corrective or preventative actions are necessary at this time.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.Manufacturer reference file#: (b)(4).
Event or Problem Description
Complaint#: (b)(4) before procedure, partially torn drape was found when opening the package.As a result, the drape was returned and reviewed at gadelius medical k.K.The torn drape, 18cm long (7.1" long), was confirmed.

• Brand Name: DRAPE, C-ARM 6600/6800, 48X84
• Common Device Name: DRAPE, SURGICAL
• 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: 21413709
• Report Number: 2182318-2025-00013
• Device Sequence Number: 8235282
• Product Code: KKX
• UDI-Device Identifier: 00618125140039
• UDI-Public: 00618125140039
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2025

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: 5403
• Device Catalogue Number: 5403
• 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: 01/23/2025
• Initial Report FDA Received Date: 02/19/2025
• 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