MAUDE Adverse Event Report: TIDI PRODUCTS LLC ST. JUDE MEDICAL CAMERA COVER CLEAR POLYETHYLENE STERILE; DRAPE, SURGICAL, EXEMPT

Model Number	33431
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 dw: procedure description via customer: it was reported that the dragonfly opstar's drive optical connector (doc) cover was found to be unsealed during preparation.Therefore, the doc cover was not used in the patient.A dragonfly optis imaging cathether with a sterile doc cover was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H3: the device was returned and evaluated by tidi products.After review of the product, it was confirmed that the pouch is not sealed.There is no indication of a previous seal, incomplete or broken seal.No other issues or damage to the product were identified.A device history record review of the affected lot number did not reveal any issues that could have contributed to the reported incident.No ncrs were identified.Production has ceased at the facility where the affected lot was manufactured, and manufacturing of this product is in the process of being moved to a new site.The quality manager for that facility has been informed of the complaint for awareness, however the process will not be an exact duplicate of the previous process.They do not currently have this sku running in production at the new facility, so we have not yet established procedures and processes for this sku at that site yet.Once it is validated, it will be integrated into the applicable documents.In the time we have been running product in the new facility, we have never had a rejection due to this condition in similar products or processes.At this time, the likely root cause appears to be related to manufacturing error, and the appropriate precautions are being taken to prevent recurrence in the new facility and process.Therefore, no corrective or preventative actions are necessary.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: ST. JUDE MEDICAL CAMERA COVER CLEAR POLYETHYLENE STERILE
• 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: 20591895
• Report Number: 2182318-2024-00140
• Device Sequence Number: 17779698
• Product Code: PUI
• UDI-Device Identifier: 00618125183883
• UDI-Public: 00618125183883
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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: 33431
• Device Catalogue Number: 33431
• Device Lot Number: 034579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2023
• 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