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

Model Number	RYSP93
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.Avid medical is a convenience kit manufacturer.The complaint component is cardinal healthcare (registration number: 1423537) part number 5558301734 tubing, suct 9/32x20, lot number 2413800364.A supplier corrective action request was issued to the component manufacturer on december 16, 2024.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 comp-wil(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
A medwatch was received that stated the suction tubing collapsed during use.The physician was using the custom spine pack to perform a posterior thoracic fusion.During the procedure, the suction collapsed making it unusable.While collapsed, patient continued to have persistent bleeding.The physician instructed the nurse to open new suction tubing.
Additional Manufacturer Narrative
Avid medical inspects convenience kits per ansi/asq z1.4: level g1, aql 1.5.Thirteen trays were inspected for this product lot with no defects found.A review of the bill of material was completed to determine if any assembly handling could contribute to the issue, no contributing factors were identified.No nonconformances were reported during kit manufacture.The component is not altered by avid medical but rather packaged with other legal medical devices for the convenience of the end-user.A supplier corrective action request was issued to the component manufacturer (cardinal health) on (b)(6) 2024.Cardinal has not responded to follow up attempts regarding request for supplier corrective action.Avid medical has added cardinal health to supplier review board for site to further address lack of response from the component manufacturer.At this time there is no history of similar complaint incidents involving this component.This product incident is documented in the complaint database and identified as complaint comp-(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: NEUROLOGICAL TRAY
• Common Device Name: NEUROLOGICAL TRAY
• Manufacturer (Section D): AVID MEDICAL, INC.; 9000 westmont drive; toano VA 23168
• Manufacturer (Section G): CARDINAL HEALTH; 1450 waukegan road; bl-4; mcgaw park IL 60085
• Manufacturer Contact: nichole coggins ; 9000 westmont drive; toano, VA 23168 ; 8287820529
• MDR Report Key: 21023758
• Report Number: 1047429-2024-00006
• Device Sequence Number: 8329567
• Product Code: OJG
• UDI-Device Identifier: 10809160419960
• UDI-Public: 10809160419960
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 02/06/2025

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 Model Number: RYSP93
• Device Catalogue Number: RYSP93
• Device Lot Number: 1624945
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 02/06/2025
• 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
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White