MAUDE Adverse Event Report: TIDI PRODUCTS LLC R15/KIT,CONSPACK,12IN(E91000AH; DRAPE, SURGICAL, EXEMPT

Model Number	20768
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported an increase in frequency of defects in e9100ah.The issue involves a component that is used to secure the blue sheet to the plastic arm-fixing bracket.This component has been detaching, and the occurrence of this issue has increased over the past two months.The affected lot numbers are as follows: lot : 68540560 lot : 68540559 lot : 68233553 lot : 039373.
Additional Manufacturer Narrative
Product is not available for return or evaluation.This report is based solely on the information provided by the customer.A review of the complaint database found one event similar to the reported issue.In this instance, product was returned and 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.Root cause was not determined in the previous instance, therefore, the current issue has been escalated to the subject matter expert (sme).Ongoing investigation is underway to determine the root cause.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).

• Brand Name: R15/KIT,CONSPACK,12IN(E91000AH
• 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: 25413128
• Report Number: 2182318-2026-00053
• Device Sequence Number: 9533720
• Product Code: PUI
• UDI-Device Identifier: 00618125152216
• UDI-Public: 00618125152216
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: 20768
• Device Catalogue Number: 20768
• Device Lot Number: 68540560
• 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: 05/11/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown