MAUDE Adverse Event Report: TIDI PRODUCTS LLC BAG, CLEAR BAND, 36X30; DRAPE, SURGICAL, EXEMPT

Model Number	CFI-655
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: fda medsun report number: (b)(4).Customer reported that a sterile c-arm equipment drape ripped while being applied to the equipment¿prior to the procedure.No images or videos and no product return are available.The event is described solely from the customer¿s account.The tear occurred before the procedure during application.No patient was involved, no breach of the sterile field during the procedure was reported, and no adverse outcome or serious injury occurred.Reported sku:cfi-655.Reported lot: 6644800 (dhr for this lot is not retrievable in our system due to record unavailability.) the closest available lot (66444801; mfg date 01/30/2025) was reviewed; no nonconformances or anomalies were identified.All evaluated production samples from representative lots passed inspection prior to release.Film tensile strength and film specification (per design requirements) met acceptance criteria in verification/ongoing qc.Packaging integrity and shelf-life verification records were also acceptable.Without product return or media, root cause could not be determined.Review of the past 36 months identified one other complaint for this sku and one unrelated complaint in the broader product family.Complaint rate for this sku is (b)(4) based on sales volume during this interval, which is within established control limits.No death or serious injury occurred; no evidence indicates this event would likely cause serious injury when standard practice (replacing a torn drape) is followed.Current evidence does not indicate a manufacturing nonconformity for the reported lot/family.No corrective or preventive action (capa) is initiated at this time; however, we will continue monthly trending.Any excursion above control limits for this failure mode will be assessed, documented, and acted upon as warranted.Manufacturer reference file: (b)(4).
Event or Problem Description
C-arm drape immediately ripped open applying to c-arm device malfunction.The device did not do what it was supposed to do.
Event or Problem Description
Supplemental medwatch being sent for additional information.

• Brand Name: BAG, CLEAR BAND, 36X30
• 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: 23930853
• Report Number: 2182318-2025-00116
• Device Sequence Number: 21086021
• Product Code: PUI
• UDI-Device Identifier: 00618125140428
• UDI-Public: 00618125140428
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: CFI-655
• Device Catalogue Number: CFI-655
• Device Lot Number: 6644800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 4913020000-2025-8005
• Patient Sequence Number: 1
• Patient Sex: Unknown