MAUDE Adverse Event Report: AVID MEDICAL, INC. ABDOMINAL TRANSPLANT PACK

Model Number	NCDS019
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.Avid medical is a convenience kit manufacturer.The complaint component (part number 5308259, lot p64795) is supplied by (b)(4) inc.Avid medical performed a device history review of complaint lot from assembly.All trays inspected detected no component defects, no additional handling was performed.All required inspections were performed prior to product release.The supplier was contacted to inquire about any known issues and to obtain the container specifications; they reported no complaints related to the container.The current inventory of the affected component in the warehouse was reviewed, and no issues were identified.Additional training was provided to the employee involved in this incident, and replacement items were issued to address the inconvenience.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
Customer reported that container within abdominal transplant pack cracked during organ (kidney) transport rendering the organ unusable.Details on the status of donor or intended recipient are unknown, the reporter indicated that their policy is to not share these details.

• Brand Name: ABDOMINAL TRANSPLANT PACK
• Common Device Name: ABDOMINAL TRANSPLANT PACK
• Manufacturer (Section D): AVID MEDICAL, INC.; 9000 westmont drive; toano VA 23168
• Manufacturer (Section G): DAWN VERMETTE INC.; 5781 flowering peach dr; providence forge VA
• Manufacturer Contact: nichole coggins ; 9000 westmont drive; toano, VA 23168 ; 8287820529
• MDR Report Key: 24115887
• Report Number: 1047429-2026-00001
• Device Sequence Number: 5890761
• Product Code: LRO
• UDI-Device Identifier: 10809160319628
• UDI-Public: 10809160319628
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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: NCDS019
• Device Catalogue Number: NCDS019
• Device Lot Number: 1599604
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 01/20/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown