MAUDE Adverse Event Report: TIDI PRODUCTS LLC KIT, CONSUMABLES PACK, 12; DRAPE, SURGICAL, EXEMPT

Model Number	5429
Medical Device Problem Code	Contamination (1120)
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.Therefore, this report is based solely on the information provided by the customer.A review of historical complaint data identified two similar complaints for debris/foreign material for this product family within the past two years.The manufacturing process was reviewed, and the most probable root cause is related to human error during manufacturing or a line-clearance issue.Production management has been informed.At this time, no further corrective or preventive actions are required.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 addressed as warranted.Manufacturer reference file: (b)(4).
Event or Problem Description
There was a hair in the sterile drape of the 5429 c-arm drape kit.Unfortunately, it was one of the last items to be placed on the sterile field which caused us to waste everything we had previously opened for the case due to contamination.

• Brand Name: KIT, CONSUMABLES PACK, 12
• 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: 24538190
• Report Number: 2182318-2026-00026
• Device Sequence Number: 12985453
• Product Code: PUI
• UDI-Device Identifier: 00618125140107
• UDI-Public: 00618125140107
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXAMPLE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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
• Device Model Number: 5429
• Device Catalogue Number: 5429
• Device Lot Number: 72108245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown