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

Model Number	5429
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: returned product evaluation confirmed the plastic cap fits over clips after assembly, with no visible deformation or misalignment.However, when assembled, the clip ends disengage easily with minimal force, preventing the cap from maintaining secure attachment as intended during use.This compromises the functional purpose of the component to hold the plastic in place.The qa investigation was unable to determine a definitive root cause.The issue has been escalated to the subject matter expert (sme) for further evaluation.Historical complaint data review identified no other similar issues reported for this part number in the last 2 years.Manufacturer reference file: (b)(4).
Event or Problem Description
The clips frequently pop off and there is a risk to it landing in the sterile field.

• 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: 23555078
• Report Number: 2182318-2025-00100
• Device Sequence Number: 15992752
• Product Code: PUI
• UDI-Device Identifier: 00618125140107
• UDI-Public: 00618125140107
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

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: 5429
• Device Catalogue Number: 5429
• Device Lot Number: 70115210
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2025
• 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