MAUDE Adverse Event Report: TIDI PRODUCTS LLC TIDI BRAND LLC; C-ARM EQUIPMENT COVER

Model Number	5403
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and is not able to be returned to tidi for a formal investigation.The product manufacture includes a sealed seam which was reported to be broken or not intact; this defect was confirmed by an image submitted by our distributor.A historical complaint review was performed, this was the first complaint of this type.The device history record was reviewed with no manufacturing issues or non-conformances noted during the manufacture of this device.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.
Event or Problem Description
Medical barrier seam was not intact, yielding open area.

• Brand Name: TIDI BRAND LLC
• Common Device Name: C-ARM EQUIPMENT COVER
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• MDR Report Key: 11890035
• Report Number: 2182318-2021-00002
• Device Sequence Number: 19062986
• Product Code: PUI
• UDI-Device Identifier: 01618125140038
• UDI-Public: (01)01618125140038(11)200907(17)250907(10)026720
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2025
• Device Model Number: 5403
• Device Catalogue Number: 5403
• Device Lot Number: 026720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1