MAUDE Adverse Event Report: AVID MEDICAL, INC. INTERVENTIONAL TRAY

Model Number	PSSC004
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Incident two of two: the product involved in the event was not returned for evaluation.Upon completion of the investigation, a follow-up report will be filed.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or caused serious injury.
Event or Problem Description
Incident two: patient was reported to have a post-surgical infection.There was medical intervention (antibiotics) provided for this patient.Additional information was requested on february 6, 2025, february 11, 2025, and february 17, 2025, the site is currently awaiting further details including details of the type of infection, type of procedure, and technique utilized by the customer.
Additional Manufacturer Narrative
Incident two of two.No samples were available for evaluation.The product was inspected per ansi/asq z1,4: level s-3 aql 1.5.120 trays were built and 8 trays were inspected with no defects found.No additional handling was documented during manufacture.Sterilization documentation was reviewed to ensure all parameters were within validated sterilization requirements.No abnormalities were found.Header bag sealer calibration was confirmed to be current.Pull and creep functional test results were reviewed from manufacture, all results were within specification.Cleaning records during manufacture were confirmed to be current with no noted issues.The site does have defined processes in place to minimize opportunity for contamination.These include: gowning procedures, environmental and bioburden monitoring.No abnormalities were found.This kit lot was built without typical exidine, chg 4oz.2% flip top that is used by end-user to clean the skin during surgical prep.The label indicated this component was not included.The customer has confirmed that they used dyna-hex 4 chg antiseptic in place for the patient.A complaint trending analysis was performed for complaints since 2021, historically there are no similar complaints.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or caused serious injury.

• Brand Name: INTERVENTIONAL TRAY
• Common Device Name: INTERVENTIONAL TRAY
• Manufacturer (Section D): AVID MEDICAL, INC.; 9000 westmont drive; toano VA 23168
• Manufacturer (Section G): AVID MEDICAL, INC.; 9000 westmont drive; toano VA 23168
• Manufacturer Contact: nichole coggins ; 9000 westmont drive; toano, VA 23168 ; 8287820529
• MDR Report Key: 21436894
• Report Number: 1047429-2025-00002
• Device Sequence Number: 4526812
• Product Code: LRO
• UDI-Device Identifier: 10809160348895
• UDI-Public: 10809160348895
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PSSC004
• Device Catalogue Number: PSSC004
• Device Lot Number: 1629088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/26/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown