MAUDE Adverse Event Report: AVID MEDICAL, INC. CARDIAC CATH PACK

Model Number	JACK449
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the blade protector was not functioning properly, leaving the blade exposed.As a result, one technician sustained a cut due to the issue.No medical intervention was required, this occurred prior to use with patient.
Additional Manufacturer Narrative
The product involved in the report is said to be available but has not been received yet.Avid medical is a convenience kit manufacturer.The complaint component is southmedic (registration number: 8022032) part number 5316285, lot number w1007576.A supplier corrective action request was issued to the component manufacturer on march 6, 2026.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 21 cfr 803, 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.
Additional Manufacturer Narrative
The device history record was reviewed, and no nonconformances were identified for the affected component.Cleaning records from the time of manufacture were also reviewed, with no issues noted.A visual inspection of current warehouse inventory for the component found no defects.All required quality inspections were completed in accordance with established procedures, with no discrepancies observed.A 12-month review of complaint data revealed no prior complaints or trends associated with this issue, indicating this is the first reported occurrence.The situation will continue to be monitored.Additionally, warehouse storage locations for the components were assessed, and the placement of the scalpel was revised to the center of the tray.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: CARDIAC CATH PACK
• Common Device Name: CARDIAC CATH PACK
• Manufacturer (Section D): AVID MEDICAL, INC.; 9000 westmont drive; toano VA 23168
• Manufacturer (Section G): SOUTHMEDIC, INC.; 50 alliance blvd; barrie ontario, canada
• Manufacturer Contact: nichole coggins ; 9000 westmont drive; toano, VA 23168 ; 8287820529
• MDR Report Key: 24545979
• Report Number: 1047429-2026-00002
• Device Sequence Number: 5597242
• Product Code: OEZ
• UDI-Device Identifier: 10809160512159
• UDI-Public: 10809160512159
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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
• Operator of Device: Health Professional
• Device Model Number: JACK449
• Device Catalogue Number: JACK449
• Device Lot Number: 1664798
• Was Device Available for Evaluation?: Yes
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/23/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown